AccessGUDID - DEVICE: AMSure® Pediatric Urine Collector (10704411008040)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Pediatric Urine Collector
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS408
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411008040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Pediatric Urine Collector

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?
63159	Paediatric urine collection/analysis kit IVD	A collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient, and quantitative test strips for various clinical chemistry analytes. Results are analysed visually or with dedicated interpretive software (not included). It can be used at home by a caregiver and at the point-of-care by a healthcare professional. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXI	Device, Paste-On For Incontinence, 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: d5332347-0833-42d5-b726-ed1135429185
Public Version Date: January 10, 2023
Public Version Number: 2
DI Record Publish Date: June 01, 2018