Blood - Urine Specimen Kit

GUDID 30859952006094

Convenience Kit

CAPITOL VIAL, INC.

Capillary blood collection system IVD

• Primary Device ID: 30859952006094
• NIH Device Record Key: defd4fed-00ae-46f0-ab8b-7b6389277757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood - Urine Specimen Kit
• Version Model Number: SA94633
• 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	10859952006090 [Primary]
GS1	30859952006094 [Package]; Contains: 10859952006090; 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

Devices Manufactured by CAPITOL VIAL, INC.

• 30859952006025 - Blood - Urine Specimen Convenience Kit: 2022-01-03 Convenience Kit
• 30859952006032 - Blood - Urine Specimen Convenience Kit: 2022-01-03 Convenience Kit
• 50859952006050 - Blood Specimen Convenience Kit: 2022-01-03 Convenience Kit
• 30859952006063 - Blood Specimen Convenience Kit: 2022-01-03 Convenience Kit
• 30859952006070 - Blood Specimen Convenience Kit: 2022-01-03 Convenience Kit
• 30859952006094 - Blood - Urine Specimen Kit: 2022-01-03Convenience Kit
• 30859952006094 - Blood - Urine Specimen Kit: 2022-01-03 Convenience Kit
• 30859952006407 - Blood Specimen Convenience Kit: 2022-01-03 Convenience Kit
• 10859952006045 - Oral-Eze: 2021-07-22 ORAL EZE KIT - PACKAGED 25 KITS PER BAG