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Latex Content

Latex Content in Nellcor, Nellcor Puritan Bennett,
Mallinckrodt® Anesthesiology Products and Shiley® Tracheostomy Products


Thank you for your interest in Nellcor products. The following information is to assist our customers and distributors in quickly and accurately identifying which Nellcor products contain latex.

Effective September 28, 1998, the United States Food and Drug Administration required that all medical device manufacturers label products that contained dry natural rubber or natural rubber latex in the product Directions for Use. Unless otherwise described in this website or the device packaging and/or Directions for Use, to the best of our knowledge, Nellcor, Nellcor Puritan Bennett, Mallinckrodt anesthesiology products and Shiley tracheostomy products do not contain dry natural rubber or natural rubber latex. If you have questions about the latex status of a particular product, please consult the product Directions for Use. If you can not locate the product Directions for Use, please contact your local sales representative.

Nellcor Anesthesia & Respiratory Products
The anesthesia and respiratory products in the table immediately under this line contain latex.

Anesthesia & Respiratory Circuits  Face mask head strap, latex breathing bags**
Anesthesia & Respiratory Face Masks Face mask head strap
Anesthesia & Respiratory Kits Face mask head strap, latex breathing bags**
Temperature Products Warmflo® pressure infusors and surgical irrigators

The following model of Infusors contain latex (hand pump and hand pump tubing &en; HP and HPDC versions only)

AD500HP below serial number 13445
AD500HPDC below serial number 13100
AD1000HP below serial number 1-6546
AD1000HPDC below serial number 1-6446

**This product has latex components which do not come in direct contact with the patient's skin. There is no known risk associated with this product due to the presence of latex.

Blood Pressure Cuffs
The supplier of the reusable blood pressure cuffs has informed us that the internal cuff bladders contain latex. The products are listed below:

Part # Description
SCBP-6R Infant reusable blood pressure cuff
SCBP-9R Child/small adult reusable blood pressure cuff
SCBP-12R Adult reusable blood pressure cuff
SCBP-15R Large arm reusable blood pressure cuff
SCBP-18R Thigh reusable blood pressure cuff

These cuff bladders are enclosed in a Dacron bag that includes a urethane lining barrier, however the hose that extends from the cuff may also contain latex. For blood pressure cuffs shipped after February 1, 1997, the blood pressure cuff hose has been treated to provide an external coating of neoprene over the exposed area, to minimize the likelihood of latex containing parts making skin contact. The shipping date of the cuff can be determined by examining the date code on the Dacron flap of the blood pressure cuff. The Dacron flap is normally tucked inside the cuff at the hose insertion point. The Nellcor Puritan Bennett SHBP-10 Hose (which interfaces between the monitor and blood pressure cuff) does not contain latex. At present, we have not validated any other vendors' reusable cuffs. Latex free neonatal cuffs are available for use with the N-3100.

Combitube® and Combitube S.A.
The Combitube® airway has always contained and presently does contain natural rubber latex in the pharyngeal cuff.

Mallinckrodt® Endotracheal Tubes:
All endotracheal tubes are latex free.

Hi-Lo® tracheal tube with Lanz pressure regulator valve (the Lanz valve contains a latex balloon inside a PVC balloon). All catalog numbers and lots.

Oximetry Sensors
In the past, the adhesive coating of the bandage on the Oxisensor® II oxygen sensor models I-20, I-20R, N-25 and N-25R, OxiCliq-N®, OxiCliq-I® oxygen sensors and the ADH-A/N disposable wraps, may have contained a minute amount of natural latex. Please note that this material is the same type used in commercial adhesive bandages. Please see below for current information on these products and other sensors.

In the past, latex-free oxygen sensors Oxisensor II N-25LF and I-20LF were made to meet customer needs. The letters LF indicated these products to be LATEX FREE. As of April 2001, the Oxisensor II oxygen transducers I-20 and N-25 have been standardized and are now labeled as LATEX-FREE. The letters LF have been removed from the product number to minimize redundancy. The initial lot number for latex free I-20s is C29017 and the initial lot number for latex free N-25s is C29018.

As of June 2002, the OxiCliq-N and OxiCliq-I oxygen sensors are latex free.

As of January 2002, the ADH-A/N is latex free.

Early Pouches of the disposable OxiMax® sensor line did not state that the products were latex free; however OxiMax sensors have always been and will continue to be latex-free.

Private label NOVAPLUS pulse oximetry sensors VN-25 and VI-20 are identical in quality and material to the Nellcor Oxisensor II oxygen sensors N-25 and I-20. They are also latex free.

On earlier RS-10 reflectance oxygen sensors, the patient contact surface and the double-sided adhesive tabs contained no natural latex. However, natural latex was a component in the adhesive used to bond the layers within the sensor. These layers are above the patient contact surface. The adhesive materials used in the sensors referenced above have been tested using the Latex ELISA Antigenic Protein (LEAP) Assay of Biomedical Extract testing at a nationally recognized independent testing laboratory. No latex antigen was detected in this test. This test has a lower detection limit of 0.03 micrograms/milliliter.

Shiley® Tracheostomy Products
The Shiley tracheostomy tube and accessory products are composed of medical grade plastics that do not contain latex material. All packaging of Shiley tracheostomy products are free of latex.

Ventilator and Respiratory Accessory Products
The following Puritan-Bennett ventilator systems do not contain latex: 740, 760, 840 (including the 806 compressor).

The 7200® series ventilator does not contain latex components that would come in contact with patients or users.

The ventilator and respiratory accessory parts listed in the following table have been confirmed to contain latex:

Part # Description
4-000612-00 Test lung
4-010793-00 SPU Filter
6-001045-00 Raindrop Nebulizer with Adult Mask (latex in strap only)
6-001124-00 Raindrop Nebulizer with Pediatric Mask (latex in strap only)
N-4403019 Test Lung Assembly

Miscellaneous Products - Content Not Yet Determined
The latex content status of the parts listed in the following table has not yet been confirmed. Until the latex content status of these parts is resolved, we suggest that they be assumed to contain latex.

Part # Description Status
F-503100-00 Breathing bag inactive part
F-503101-00 Breathing bag inactive part
F-503102-00 Breathing bag inactive part
F-503104-00 Breathing bag  
F-503202-00 Breathing bag inactive part
F-651100-00 Form It Mask  
F-651101-00 Form It Mask  
F-651103-00 Form It Mask  
F-651104-00 Form It Mask  
F-651105-00 Form It Mask inactive part
F-651106-00 Form It Mask  

Packaging of Nellcor Critical Care Products
All packaging of Nellcor Critical Care Products are free of latex. The table immediately following this line is a quick reference guide to latex free products.

Product Line Latex Content
Airway monitoring adapter No Products
Basic and Specialty Endotracheal Tubes - current shipments. No Products
Capno-Flo / Capno-Flo basic resuscitators No Products
INdGO manual resuscitators No Products
DAR Filters, HME's & Filter/HME's No Products
EasyCap® / Pedi-Cap® CO2 detector No Products
Gas sampling lines No Products
Stylets, suction catheters, ventrol levin, infant feeding tubes, lavacuators and other accessories No Products
Shiley tracheostomy tubes and accessories No Products
Thermocouple & Thermistor temperature adapters, monitors & cables No Products
Thermocouple & Thermistor temperature probes No Products
WarmFlo® FW-538 & FW-588 fluid warmers: WarmFlo FW-100 and FW-250 fluid cassettes No Products
WarmFlo pressure infusors and irrigation pumps; the following models; AD500 / AD500FW / AD1000 / AD1000FW / AD1500 /AD1500FW / AD2000 / AD2000FW / SI1000 / SI1000FW / SI2000 / SI2000FW / SI3000 / SI3000FW No Products - Please see Nellcor Anesthesia and Respiratory Products latex table above, for early versions of the HP and DHPDC Infusors that contained latex in the hand pump and hand pump tubing.
WarmTouch® warming blankets & blowers No Products

Customer Inquiries About Latex in Products
For questions about Nellcor, Nellcor Puritan Bennett, Mallinckrodt, Aequitron, EdenTec or Infrasonics products or versions not listed, please contact:

In the United States and Canada:

Contact the Nellcor Puritan Bennett Technical Services Department

 Tel: 1.800.635.5267 select 3, or
        1.925.463.4000 ext. 6300
Fax: 1.925.463.4720

In Europe, the Middle East and Africa:

Contact your local sales representative
In Mexico, and Central and South America:

Contact the Nellcor Puritan Bennett Technical Services Department

Tel:  +1.925.463.4000, ext. 6300
Fax: 1.925.463.4720

Asia (except Japan) and the Pacific Region:

Mallinckrodt Asia Pacific Pte. Ltd.
(Office located in Singapore)

Tel:  +65.738.4333
Fax: +65.738.4334
In Japan:

Mallinckrodt Japan:

Tel:  +81.3.5363.5720
Fax: +81.3.5379.5817
Nellcor Puritan Bennett Sleep Products

Please contact Technical Services:

Eden Trace Recording Products
Sandman, Sleep lab diagnostic products

Tel:  1.800.663.3336, or
        1.613.238.1840
Fax: 1.613.238.1291

CPAP and Bi-Level Systems

Tel:  1.800.255.6774 select "3", or         1.760.603.5300
Fax: 1.760.603.6684

For Mallinckrodt, Liebel-Flarsheim, Shiley products, including those from Imaging, Pharmaceuticals, Nuclear Medicine, Critical Care and Mallinckrodt Baker:

Liebel-Flarsheim International Product Support:

Liebel-Flarsheim Technical Support

Tel:  1.800.877.0791 or
        1.513.761.2700
Fax: 1.513.948.7226

Please include Product Model, Institution Name, Contact Person, Facility Address, Phone and Fax Number, and Question(s). International Mail, Faxes and calls accepted.

Mallinckrodt Imaging

Imaging: Contrast media, guide wires, catheters, inflation/deflation devices, ultrasound contrast injectable media, and warmer boxes.

Professional Services

Tel:  1.888.744.1414 select "2", or
        1.314.654.2000
Fax: 1.314.654.8206
Mallinckrodt Critical Care
(Anesthesiology Products)

Contact the Technical Services Department

Tel:  1.888.744.1414, select "3", or
        1.314.654.2000
Fax: 1.314.654.8206
Shiley Tracheostomy Products

Contact the Technical Services Department

Tel:  1.800.635.5267 select "3", or
        1.925.463.4000 ext. 6300
Fax: 1.925.463.4720

Mallinckrodt Pharmaceutical Dosage Products

Contact Professional Services

Tel:  1.888.744.1414 select "2", or
        1.314.654.2000
Fax: 1.314.654.8206
Mallinckrodt Nuclear Medicine
Nuclear Medicine: Radioisotopes, generators, lead buckets (to hold isotopes)

Contact Professional Services

Tel:  1.888.744.1414 select "2", or
        1.314.654.2000
Fax: 1.314.654.8206

 
 


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