AccessGUDID - DEVICE: U-Bag Urine Collector (00840113231751)

GUDID

Device Identifier (DI) Information

Brand Name: U-Bag Urine Collector
Version or Model: 7540
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00840113231751
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Stork U-Bag, Urine Collection Bag, 10mL, Preemie, Single Specimen, Cloth Adhesive, Sterile, 1/pouch, 100 pouches/box

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?
58930	Adhesive paediatric urine collection bag, closed-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 not designed with an opening for urine drainage and is typically used for biochemical, cytological and/or bacteriological sampling. 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
No Device Sizes

Device Record Status

Public Device Record Key: fe9c6ea0-dc94-4c3c-97c0-db6a74f20e9d
Public Version Date: March 07, 2023
Public Version Number: 1
DI Record Publish Date: February 27, 2023