Blood Collection Kit

GUDID 00850037506170

The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag.

VERICEL CORPORATION

Specimen container mailer, non-insulated

• Primary Device ID: 00850037506170
• NIH Device Record Key: 71681468-08ab-4c4e-870c-b1df152d91fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Collection Kit
• Version Model Number: N/A
• Company DUNS: 079745570
• Company Name: VERICEL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00850037506170 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 2022-10-03
• Device Publish Date: 2022-09-23

Devices Manufactured by VERICEL CORPORATION

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• 00850037506002 - MACI Arthroscopic Instruments: 2024-09-03 MACI Applicator
• 00850037506019 - MACI Arthroscopic Instruments: 2024-09-03 15mm V-Shuttle delivery device
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