BiPAP - Transcutaneous CO2 Connection Cable - Respironics, Inc.

Duns Number:080728314

Device Description: Transcutaneous CO2 Connection Cable

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More Product Details

Catalog Number

1146885

Brand Name

BiPAP

Version/Model Number

1146885

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MNT

Product Code Name

Ventilator, continuous, minimal ventilatory support, facility use

Device Record Status

Public Device Record Key

b28a4b3e-9114-4be7-bed2-f46c6ab43ad2

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRONICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 151
2 A medical device with a moderate to high risk that requires special controls. 3279