Apheresis Needle with MASTERGUARD Protector 4R2441

GUDID 10811137012418

Apheresis Needle with MASTERGUARD Protector 17 Ga. x 1-1/4'' BE. Sterile Fluid Path.

FENWAL, INC.

Apheresis system tubing set

• Primary Device ID: 10811137012418
• NIH Device Record Key: eaa80718-d45e-4b12-8d05-7e978ec15222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apheresis Needle with MASTERGUARD Protector
• Version Model Number: 4R2441
• Catalog Number: 4R2441
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137012411 [Primary]
GS1	10811137012418 [Package]; Contains: 00811137012411; Package: Case [250 Units]; In Commercial Distribution

FDA Product Code

• FIE: Needle, Fistula

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: 2016-09-02

Devices Manufactured by FENWAL, INC.

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• 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