Bard Wire-Guided Jejunal Feeding/Gastric Decompression Tube - 9 Fr Guidewire J-Tube - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: 9 Fr Guidewire J-Tube

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More Product Details

Catalog Number

000732

Brand Name

Bard Wire-Guided Jejunal Feeding/Gastric Decompression Tube

Version/Model Number

000732

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

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

d0438ca3-9494-41f2-8dcd-e840655eb98b

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

20801741051665

Quantity per Package

15

Contains DI Package

10801741051668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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