McKesson 89228

GUDID 00850015517167

Premium Liquid urine diptube style with micro- 15mL

KOVA INTERNATIONAL, INC.

Urine sediment IVD, control

• Primary Device ID: 00850015517167
• NIH Device Record Key: 3cc13205-86e6-42eb-bbda-a61d4dbb81ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: McKesson
• Version Model Number: 89228
• Catalog Number: 89228
• Company DUNS: 078780990
• Company Name: KOVA INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015517167 [Primary]

FDA Product Code

• JJW: Urinalysis Controls (Assayed And Unassayed)

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: 2020-09-10
• Device Publish Date: 2020-09-02

On-Brand Devices [McKesson]

• 00850015517167: Premium Liquid urine diptube style with micro- 15mL
• 00855617006279: Premium Liquid urine bottle style with micro- 120mL
• 00855617006248: Premium Liquid urine dropper style- 25mL
• 00855617006224: Premium Liquid urine dropper style- 5mL