BAXJECT II NTD 1505834

GUDID 50642621003944

BAXALTA US INC.

Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set

• Primary Device ID: 50642621003944
• NIH Device Record Key: b689da4b-2974-468c-8e40-766dce246d75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAXJECT II NTD
• Version Model Number: 1505834
• Catalog Number: 1505834
• 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	00642621003949 [Primary]
GS1	20642621003943 [Package]; Contains: 00642621003949; Package: Box [5 Units]; In Commercial Distribution
GS1	50642621003944 [Package]; Contains: 20642621003943; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042410

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: 4
• 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
• 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