McKesson 89228

GUDID 00850015517167

Premium Liquid urine diptube style with micro- 15mL

KOVA INTERNATIONAL, INC.

Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control 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