AccessGUDID - DEVICE: Bard® Rectal Tube (00801741045981)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Rectal Tube
Version or Model: 0006520
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0006520
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741045981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® Rectal Tube

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":	Yes
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?
14187	Rectal/colonic irrigation nozzle, single-use	An invasive luminal device intended to be inserted into the rectum and/or colostomy site for the administration of irrigation fluid into the rectum and/or large intestines during a rectal irrigation, colonic lavage, enema, and/or colostomy site irrigation procedure. Available in a variety of designs, it may be referred to as a cone, tip, speculum, or rectal catheter, and may include an inflatable balloon for retention. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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: No
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: 20 Inch
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: 9ae006b1-5cb3-4927-9fdc-a05f38ba7f14
Public Version Date: June 19, 2024
Public Version Number: 5
DI Record Publish Date: August 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10801741045988	50	00801741045981		In Commercial Distribution	BX
20801741045985	4	10801741045988		In Commercial Distribution	CA

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)526-4455
Email: medical.services@crbard.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES