BAXJECT II Hi-Flow

GUDID 00850025688871

Needleless Transfer Device

Takeda Pharmaceuticals U.S.A., Inc.

Medication transfer set

• Primary Device ID: 00850025688871
• NIH Device Record Key: 09d01592-ce04-47a4-b753-1eb1618cc792
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAXJECT II Hi-Flow
• Version Model Number: 3400769
• Company DUNS: 041877817
• Company Name: Takeda Pharmaceuticals U.S.A., 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	00642621074000 [Previous]
GS1	00850025688871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092318

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: 2024-06-20
• Device Publish Date: 2024-06-12

Devices Manufactured by Takeda Pharmaceuticals U.S.A., Inc.

• 00850025688871 - BAXJECT II Hi-Flow: 2024-06-20Needleless Transfer Device
• 00850025688871 - BAXJECT II Hi-Flow: 2024-06-20 Needleless Transfer Device
• 00850025688864 - BAXJECT II: 2024-03-08 Needleless Transfer Device
• 00850025688888 - Anti-Drug Antibody Biomarker Specimen Collection Kit: 2023-11-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectings