AccessGUDID - DEVICE: GLOBAL HEALTHCARE (00872237004751)

GUDID

Device Identifier (DI) Information

Brand Name: GLOBAL HEALTHCARE
Version or Model: UB-P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GHC HEALTHCARE, INC.

Primary DI Number: 00872237004751
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884718776 *Terms of Use

Device Description: URINE BAG, 2,000ML, PEAR SHAPE, DRIP CHAMBER, HANGER, SAMPLING PORT, FLUID PATHWAY STERILE.

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?
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. 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
No Device Sizes

Device Record Status

Public Device Record Key: 38e3a5a6-11a9-400b-8b55-387034ffbd2a
Public Version Date: January 08, 2021
Public Version Number: 5
DI Record Publish Date: September 12, 2016