FirstBurst Urine Collection Device v2 C06-0005-85

GUDID B714C060005

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

Diagnostics For The Real World Limited

Non-evacuated urine specimen container IVD, no additive

• Primary Device ID: B714C060005
• NIH Device Record Key: c4964cd1-af45-43d4-ac89-468e05887705
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FirstBurst Urine Collection Device v2
• Version Model Number: 2.0
• Catalog Number: C06-0005-85
• Company DUNS: 141057898
• Company Name: Diagnostics For The Real World Limited
• Device Count: 85
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com
• Phone: +14087731511
• Email: service@drw-ltd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B714C060005 [Unit of Use]
HIBCC	B714C060005850 [Primary]

FDA Product Code

• NNI: Container, Specimen, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30

Devices Manufactured by Diagnostics For The Real World Limited

• B714C060003200 - FirstBurst Urine Collection Device: 2023-07-10 For the collection of the first catch male urine specimen. For in vitro diagnostic use.
• B714C060005 - FirstBurst Urine Collection Device v2: 2023-07-10For the collection of the first catch male urine specimen. For in vitro diagnostic use.
• B714C060005 - FirstBurst Urine Collection Device v2: 2023-07-10 For the collection of the first catch male urine specimen. For in vitro diagnostic use.