BAXJECT II Hi-Flow NTD 340601

GUDID 00642621029383

BAXALTA US INC.

Medication transfer set

• Primary Device ID: 00642621029383
• NIH Device Record Key: 5b568476-705f-4ddd-a61f-c9d81fe6de20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAXJECT II Hi-Flow NTD
• Version Model Number: 340601
• Catalog Number: 340601
• Company DUNS: 079887619
• Company Name: BAXALTA US 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00642621029383 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

Devices Manufactured by BAXALTA US INC.

• 50642621003944 - BAXJECT II NTD: 2018-07-06
• 50642621029234 - FlowEase [Subcutaneous] Infusion Set: 2018-07-06
• 50642621029241 - FlowEase [Subcutaneous] Infusion Set: 2018-07-06
• 50642621029258 - FlowEase [Subcutaneous] Infusion Set: 2018-07-06
• 00642621029383 - BAXJECT II Hi-Flow NTD: 2018-07-06
• 00642621029383 - BAXJECT II Hi-Flow NTD: 2018-07-06