4C2223

GUDID 10811137010698

Blood Component Infusion Set- Standard Blood Component Filter Female Luer. Sterile Fluid Path

FENWAL, INC.

Blood transfusion set

• Primary Device ID: 10811137010698
• NIH Device Record Key: bd52756e-941c-4441-ace6-e05c8f9fd1c2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4C2223
• Catalog Number: 4C2223
• Company DUNS: 794519020
• Company Name: FENWAL, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137010691 [Primary]
GS1	10811137010698 [Package]; Contains: 00811137010691; Package: Box [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073339

FDA Product Code

• BRZ: Set, Blood Transfusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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