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FirstBurst Urine Collection Device v2

FDA UDI

Class I (US FDA UDI)

by Diagnostics for the Real World Ltd

Identity

Trade Name
FirstBurst Urine Collection Device v2 FDA UDI
Generic Name
Non-evacuated urine specimen container IVD, no additive FDA UDI
Device Name
For the collection of the first catch male urine specimen. For in vitro diagnostic use. FDA UDI
Model / Reference
2.0 FDA UDI
Description
For the collection of the first catch male urine specimen. For in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
C06-0005-85 FDA UDI
Primary DI / UDI-DI
B714C060005850 FDA UDI
FDA Product Code
NNI FDA UDI
GMDN Term
Non-evacuated urine specimen container IVD, no additive FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-evacuated urine specimen container IVD, no additive

FirstBurst Urine Collection Device v2 by Diagnostics for the Real World Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-evacuated urine specimen container IVD, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostics for the Real World Ltd

Sources (1)

  • FDA UDI c4964cd1-af45-43d4-ac89-468e05887705 36 fields · synced Jun 8, 2026