PVC Transfer Bag

GUDID 20816203023296

Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product

ORIGEN BIOMEDICAL, INC.

Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag Blood washing/centrifugation bag

• Primary Device ID: 20816203023296
• NIH Device Record Key: ccb10a5d-ac30-4ef4-9b34-14f88fd33757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PVC Transfer Bag
• Version Model Number: 10-200-CS25
• 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
• 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	10816203023299 [Primary]
GS1	20816203023296 [Package]; Contains: 10816203023299; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK140116

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: 2021-01-08
• Device Publish Date: 2017-06-06

On-Brand Devices [PVC Transfer Bag]

• 20816203023296: Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a
• 20816203023289: Two 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and
• 20816203023272: One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and