BAXJECT II Hi-Flow 3400691

GUDID 00642621074000

Needleless Transfer Device

Shire Human Genetic Therapies, Inc.

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• Primary Device ID: 00642621074000
• NIH Device Record Key: 3bbbc0b5-5537-48fa-a107-f24df5e3e287
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAXJECT II Hi-Flow
• Version Model Number: 3400691
• Catalog Number: 3400691
• Company DUNS: 626119668
• Company Name: Shire Human Genetic Therapies, 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	00642621029383 [Previous]
GS1	00642621074000 [Primary]

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by Shire Human Genetic Therapies, Inc.

• 00642621074000 - BAXJECT II Hi-Flow: 2023-10-12Needleless Transfer Device
• 00642621074000 - BAXJECT II Hi-Flow: 2023-10-12 Needleless Transfer Device
• 05060147022339 - Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient: 2021-04-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting