4C2161

GUDID 10811137010407

Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path

FENWAL, INC.

Blood transfusion set

• Primary Device ID: 10811137010407
• NIH Device Record Key: 9f0912e9-51b2-4f69-98fb-8403b1645eda
• Commercial Distribution Discontinuation: 2018-03-11
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 4C2161
• Catalog Number: 4C2161
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137010400 [Primary]
GS1	10811137010407 [Package]; Contains: 00811137010400; Package: Box [48 Units]; Discontinued: 2018-03-11; Not 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: 4
• Public Version Date: 2019-11-08
• 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