AccessGUDID - DEVICE: Sterile Specimen Cup with Temp Strip (00850014433239)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Specimen Cup with Temp Strip
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DU3100
Company Name: DISTRIBUTION UNLIMITED, LLC

Primary DI Number: 00850014433239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926603486 *Terms of Use

Device Description: The urine collection cup is a sterile plastic cup with a temperature strip and leak-resistant lid with a capacity of 90mL. This product can be used for urine, blood, and semen sample testing.

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):	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?
57923	Drug-testing urine specimen container IVD	A covered plastic receptacle with a temperature strip and/or tamperproof seal intended to be used for the collection, and preservation and/or transport, of a urine specimen for drug testing and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	Container, Specimen, 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
Total Volume: 90 Milliliter

Device Record Status

Public Device Record Key: ada65324-a0a2-4d6f-a0f3-a5508ca50f51
Public Version Date: August 21, 2020
Public Version Number: 1
DI Record Publish Date: August 13, 2020