Blood - Urine Specimen Kit

GUDID 30859952006094

Convenience Kit

CAPITOL VIAL, INC.

Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD Capillary blood collection system IVD 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