AccessGUDID - DEVICE: PEDIATRIC URINE COLLECTORS, CLEAN (10687225793749)

GUDID

Device Identifier (DI) Information

Brand Name: PEDIATRIC URINE COLLECTORS, CLEAN
Version or Model: 05001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05001-00-SCB (Y5178897)
Company Name: PRECISION DYNAMICS CORPORATION

Primary DI Number: 10687225793749
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008486367 *Terms of Use

Device Description: PEDIATRIC URINE COLLECTORS, CLEAN, 100/Box, 500/Case

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):	No
Over the Counter (OTC):	Yes
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?
58929	Adhesive paediatric urine collection bag, open-ended	A flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/pre-adolescent paediatric patient. It is designed with an opening for urine drainage and is typically used for urine output measurement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOA	Device, Paste-On For Incontinence, Non-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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 798bcbe9-30a8-46d4-8ea8-927fb12f7bc2
Public Version Date: June 28, 2023
Public Version Number: 1
DI Record Publish Date: June 20, 2023