AccessGUDID - DEVICE: FirstBurst Urine Collection Device v2 (B714C060005850)

GUDID

Device Identifier (DI) Information

Brand Name: FirstBurst Urine Collection Device v2
Version or Model: 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C06-0005-85
Company Name: Diagnostics For The Real World Limited

Primary DI Number: B714C060005850
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 85
Labeler D-U-N-S® Number*: 141057898 *Terms of Use

Device Description: For the collection of the first catch male urine specimen. For in vitro diagnostic use.

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?
46023	Non-evacuated urine specimen container IVD, no additive	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNI	Container, Specimen, 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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4964cd1-af45-43d4-ac89-468e05887705
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: June 30, 2023