AccessGUDID - DEVICE: Bard® Adapter and Tubing (00801741045745)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Adapter and Tubing
Version or Model: 000538
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000538
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741045745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® Adapter and Tubing for Leg Bags to Male External Catheter or Foley Catheter

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63257	Urethral/suprapubic catheter valve-connector	A small, sterile valve intended to be connected to a urethral and/or suprapubic catheter to allow intermittent bladder drainage/filling (as an alternative to continuous drainage). As the bladder is intended to store urine between drainage it may be intended to help maintain bladder tone/capacity. It is typically a small plastic two-way connector with an integrated faucet (stopcock). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Inch

Device Record Status

Public Device Record Key: 53c12e4f-a5c9-44cc-a7de-0a173bb7b0c8
Public Version Date: July 31, 2023
Public Version Number: 3
DI Record Publish Date: August 22, 2016