Feeding/Decompression Tube - Feeding/D-Comp - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: Feeding/D-Comp

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More Product Details

Catalog Number

000395

Brand Name

Feeding/Decompression Tube

Version/Model Number

000395

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2016

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"

Yes

For Single-Use

Yes

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Record Status

Public Device Record Key

5d8dd259-8d88-493b-bd5d-ac1cbed45c73

Public Version Date

April 12, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

10801741081061

Quantity per Package

12

Contains DI Package

00801741081064

Package Discontinue Date

June 27, 2016

Package Status

Not in Commercial Distribution

Package Type

CA

"BARD ACCESS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3348
U Unclassified 8