Blood - Urine Specimen Convenience Kit

GUDID 30859952006032

Convenience Kit

CAPITOL VIAL, INC.

Capillary blood collection system IVD

• Primary Device ID: 30859952006032
• NIH Device Record Key: ae0416cf-61c8-4705-b936-83c17bdcfaf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood - Urine Specimen Convenience Kit
• Version Model Number: SA93508
• Company DUNS: 151639481
• Company Name: CAPITOL VIAL, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10859952006038 [Primary]
GS1	30859952006032 [Package]; Contains: 10859952006038; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101502

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-01-03
• Device Publish Date: 2018-08-31

On-Brand Devices [Blood - Urine Specimen Convenience Kit]

• 00859952006123: Blood - Urine Specimen Convenience Kit
• 30859952006032: Convenience Kit
• 30859952006025: Convenience Kit