AccessGUDID - DEVICE: CARDINAL HEALTH (10885380126376)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: LB600T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LB600T
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380126376
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Standard Leg Bag 600ml; Pre-connected 18 in. Entension Tube; Twist Valve; Fabric Leg Straps; Sterile Fluid Pathways

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?
58919	Wearable adult urine collection bag, closed-ended	A flexible plastic pouch designed to connect to a urinary catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is not designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility and is disposed of when full. 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
Height: 18 Inch

Device Record Status

Public Device Record Key: ead56318-be7b-4a64-9b25-0a178274a298
Public Version Date: April 07, 2021
Public Version Number: 4
DI Record Publish Date: July 19, 2019