H.E.L.P.® 7061192

GUDID 04046964699467

HELP HEPARIN 400,000 IU V 50/40ML US

B.Braun Avitum AG

Apheresis kit

• Primary Device ID: 04046964699467
• NIH Device Record Key: fb08f074-0693-4419-a1fa-aac607d9c9ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.E.L.P.®
• Version Model Number: 7061192
• Catalog Number: 7061192
• Company DUNS: 343689704
• Company Name: B.Braun Avitum AG
• Device Count: 80
• 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

Customer Support Contacts

• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955348367 [Unit of Use]
GS1	04046964699467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P940016

FDA Product Code

• MMY: LIPOPROTEIN, LOW DENSITY, REMOVAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-29
• Device Publish Date: 2016-03-09

On-Brand Devices [H.E.L.P.®]

• 04046964699467: HELP HEPARIN 400,000 IU V 50/40ML US
• 04046964696770: HELP ULTRAFILTER HIPS 20 US
• 04046964695865: HELP HOT FUTURA SET US
• 04046964156731: H.E.L.P. ACETATPUFFER HOT US / CA