AccessGUDID - DEVICE: Leg Bag (00801741050862)

GUDID

Device Identifier (DI) Information

Brand Name: Leg Bag
Version or Model: 150732
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 150732
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741050862
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve, 2 Fabric Leg Straps, Large (32oz)

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58923	Wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

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
Total Volume: 32 Fluid Ounce

Device Record Status

Public Device Record Key: 57731860-f284-43bb-be63-2794f092ccdd
Public Version Date: April 07, 2021
Public Version Number: 3
DI Record Publish Date: September 22, 2020