4R2422

GUDID 10811137010766

Red Cell Freezing Pack 2000 mL. Sterile Fluid Path

FENWAL, 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 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: 10811137010766
• NIH Device Record Key: 1ca2c168-a7dc-445c-8d20-deb8856b977d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4R2422
• Catalog Number: 4R2422
• Company DUNS: 794519020
• Company Name: FENWAL, INC.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx
• Phone: 1-800-933-6925
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137010769 [Primary]
ICCBBA	0FE04R2422 [Secondary]
GS1	10811137010766 [Package]; Contains: 00811137010769; Package: Box [48 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-12

Devices Manufactured by FENWAL, INC.

• 20811137010626 - Transfer Pack: 2023-04-21 Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
• 20811137010497 - Transfer Pack: 2022-06-17 Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path
• 20811137010619 - Transfer Pack: 2022-06-17 Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
• 20811137010541 - Transfer Pack: 2019-11-08 Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
• 0FE04R2024 - Transfer Pack: 2019-11-08 Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path
• 20811137010633 - Transfer Pack: 2019-11-08 Transfer Pack Container 600 mL with Coupler. Sterile Fluid Path
• 20811137010657 - NA: 2019-11-08 Plasma Transfer Sets with Spike and Male Luer Adapter. Sterile Fluid Path
• 20811137010701 - NA: 2019-11-08 Plasma Transfer Sets with Two Spikes. Sterile Fluid Path