Fenwal DXT Relay Release 2.2 5S9803

GUDID 00811137013043

Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and Computer Systems. The data may also be stored in and accessed from Fenwal DXT Relay's database.

FENWAL, INC.

Blood bank information system application software Blood bank information system application software

• Primary Device ID: 00811137013043
• NIH Device Record Key: eac0a2b7-8dc8-4150-9c63-9195430aadd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenwal DXT Relay Release 2.2
• Version Model Number: 5S9803
• Catalog Number: 5S9803
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137013043 [Primary]

FDA Product Code

• MMH: Software, Blood Bank, Stand Alone Products

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-05

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