Cryostore Harvest Kit

GUDID 10816203020526

Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container

• Primary Device ID: 10816203020526
• NIH Device Record Key: b0bc9b37-8c8f-456b-8985-6de30247a3b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryostore Harvest Kit
• Version Model Number: CS750Y12S
• Company DUNS: 625272232
• Company Name: ORIGEN BIOMEDICAL, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203020526 [Primary]
GS1	20816203020523 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK030036

FDA Product Code

• KSR: Container, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-17
• Device Publish Date: 2016-09-23

Devices Manufactured by ORIGEN BIOMEDICAL, INC.

• 10816203020656 - Cryobag: 2024-04-23 Cryobag, 09x15, Kapton/FEP
• 10816203022193 - TubeSet Adapter: 2024-04-23 Adapter tube set, 4 bag spikes x 1 Male luer, 40cm
• 10816203021462 - TissueVault: 2023-04-11 Cell and Tissue Freezing bag, 19 x 36 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
• 00816203022202 - O-Wrap: 2023-04-11 O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
• 00816203022226 - O-Wrap: 2023-04-11 O-Wrap, overwrap pouch for freezing,19x50cm
• 00816203022257 - O-Wrap: 2023-04-11 O-Wrap, overwrap pouch for freezing, 24x36cm
• 00816203022585 - O-Wrap: 2023-04-11 O-Wrap, overwrap pouch for freezing, 9x9cm.
• 00816203022592 - O-Wrap: 2023-04-11 O-Wrap, overwrap pouch for freezing, 9x18cm