CryoStore CS750KS

GUDID 20816203023746

CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed

ORIGEN BIOMEDICAL, INC.

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

• Primary Device ID: 20816203023746
• NIH Device Record Key: 048a910b-0be4-46bf-a656-ca53a207f84a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoStore
• Version Model Number: CS750KS
• Catalog Number: CS750KS
• 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
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• 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	10816203023749 [Primary]
GS1	20816203023746 [Package]; Contains: 10816203023749; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [CryoStore]

• 20816203023647: CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed
• 20816203023586: CryoStore multiple bag set, six 20 EVA freezing bags, 20-30ml, "V6" Tube Set
• 20816203023579: CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "NS" Tube Set
• 20816203023562: CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "F" Tube Set
• 20816203023555: CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "N" Tube Set
• 20816203023425: Cryostore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, singly packed
• 20816203023302: CryoStore 50 EVA Freezing Bag, 7-Bag Set, 10-30ml, "V9" Tube Set
• 10816203023169: Cryostore 50 EVA Freezing Bag, 4-bag Set, 10-30ml, "V8" tubing set
• 20816203023159: CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set
• 10816203022865: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 24
• 10816203022841: Cryostore 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24
• 20816203022244: Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
• 10816203022230: Cryostore 2000 EVA Freezing Bag, 180-450ml, "Standard" Tube Set, case of 24
• 10816203021547: Cryostore 2500 Conical EVA Freezing Bag, 730-810ml, " Y14" Tubing Set, case of 12
• 20816203021537: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
• 20816203021520: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
• 20816203021513: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
• 10816203021509: Cryostore 750 EVA 3-Bag set with drip spikes, 80-190ml, case of 6 sets
• 10816203021493: Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case
• 10816203021455: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
• 20816203021445: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
• 20816203021438: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
• 20816203021421: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 24
• 10816203021417: Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
• 20816203021407: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "Y3" Tubing Set, case of 24
• 10816203021387: Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
• 10816203021370: Custom 50 EVA 2-Bag set with spikes, 10-30ml, 1 set per pouch, case of 12
• 10816203021363: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed in OW
• 10816203021356: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, triply packed
• 10816203021349: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed
• 20816203021339: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, M3 tube set, case of 24
• 20816203021322: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
• 10816203021318: Cryostore 50 EVA Freezing Bag, 10-30ml, "F4" Tubing Set, double aseptically pouched, case of 12
• 20816203021278: Cryostore 50 EVA Freezing Bag, 10-30ml, "F15" Tubing Set, case of 24
• 10816203021264: Cryostore 500 EVA 3-Bag set with spikes, 55-100ml, 1 set per pouch, case of 8 sets
• 10816203021257: Custom 500ml EVA 2-bag set with spikes, 1 set per pouch, 12 sets per case
• 20816203021247: Custom 500ml EVA 2-bag set with spikes, 2 sets per Tyvek pouch, 12 sets per case
• 10816203021233: Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed in OW
• 10816203021226: Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
• 20816203021216: Cryostore 500 EVA Freezing Bag, 55 - 100 ml "M4" Tubing Set, case of 24
• 20816203021209: Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
• 10816203021196: Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12
• 10816203021189: Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
• 20816203021179: Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 24
• 10816203021165: Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F1" Tubing Set, double aseptic packed, case of 12
• 20816203021155: Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F16" Tubing Set, case of 24
• 20816203021148: Cryostore 500 EVA Freezing Bag, 55 - 100 ml Standard Tubing Set, case of 24
• 20816203021131: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, 4 per triply pouched,
• 20816203021124: Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24
• 20816203021117: Cryostore 400ml EVA Freezing Bag with standard tube set, 24 per case