Diacap® 7204001

GUDID 04046964319921

Diacap? Polysulfone® LOPS 12

B.Braun Avitum AG

Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 04046964319921
• NIH Device Record Key: 5a1b4197-0686-4cb2-b4f5-69089e91e8c5
• Commercial Distribution Discontinuation: 2019-02-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Diacap®
• Version Model Number: 7204001
• Catalog Number: 7204001
• Company DUNS: 343689704
• Company Name: B.Braun Avitum AG
• Device Count: 20
• 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)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04039239089711 [Unit of Use]
GS1	04046964319921 [Primary]

FDA Product Code

• FJI: DIALYZER, CAPILLARY, HOLLOW FIBER

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: 2020-03-03
• Device Publish Date: 2015-08-09

On-Brand Devices [Diacap®]

• 04046964610837: Diacap® Pro 16H
• 04046964610813: Diacap® Pro 19H
• 04046964610776: Diacap® Pro 13H
• 04046964319983: DIACAP HIPS 12 PS DIALYZER
• 04046964319921: Diacap? Polysulfone® LOPS 12
• 04046964319891: DIACAP LOPS 10 PS DIALYZER
• 04046964320002: Diacap Polysulfone® HI PS 15 Dialyzer
• 04046964319969: Diacap Polysulfone® HI PS 10 Dialyzer
• 04046964319945: Diacap Polysulfone® LO PS 15 Dialyzer
• 04039239090496: Diacap® Ultra Dialysis Fluid Filters
• 04046964320040: Diacap Polysulfone® HI PS 20 Dialyzer
• 04046964320026: Diacap Polysulfone® HI PS 18 Dialyzer
• 04046963178109: DIACAP ULTRA DF FILTER CA & US
• 04046955659654: Diacap Pro 19H
• 04046955659630: Diacap Pro 16H
• 04046955659616: Diacap Pro 13H