B.BRAUN 7102315

GUDID 04046964762734

OPTION STAFF CALL SW9.XX

B.Braun Avitum AG

Haemodialysis system, institutional

• Primary Device ID: 04046964762734
• NIH Device Record Key: 7a81f560-7a33-42cb-b6b4-5bd9f6e002e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.BRAUN
• Version Model Number: 7102315
• Catalog Number: 7102315
• Company DUNS: 343689704
• Company Name: B.Braun Avitum AG
• Device Count: 200
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046963686765 [Unit of Use]
GS1	04046964762734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083460

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-04-24
• Device Publish Date: 2015-08-09

On-Brand Devices [B.BRAUN]

• 04046964966149: ABPM CUFF, EXTRA LARGE, LATEX FREE (XL)
• 04046964762734: OPTION STAFF CALL SW9.XX
• 04046964738388: CCS CONNECTOR FOR 3 CONCENTRATES
• 04046964337017: The Plasmat® Futura Sy stem
• 04046964319860: H.E.L.P. Heparin Sodium Solution 30 mL
• 04046964290169: HELP ACETATE BUFFER 4.85 US 3000ML
• 04046964290152: HELP BIC EL HCL US 5000ML
• 04046964290145: HELP 0,9 % SODIUM CHLORIDE US 3000ML
• 04046964290138: HELP 0,9 % SODIUM CHL. SET US 500/1500ML
• 04046963711184: EMPTY BAGS FOR DIALYSATE FUTURA (US)
• 04046964231834: HELP HEPARIN ADSORBER 400 US/CA
• 04046964133534: HELP FUTURA SET WITH 4 FILTERS (US)
• 04046964091827: OPTION ADIMEA
• 04046964091728: Adimea™ Dialysis Measurement Sy stem (Kt/V) for Dialog+®
• 04046964057434: Patient Therapy Card (7105232)
• 04046963847418: EMPTY BAG CONNECTION LINE (US)
• 04046963845797: H.E.L.P. HEMOSELECT L 0,5
• 04046963845780: H.E.L.P. HEPARIN ADSORBER (US)
• 04046963845773: H.E.L.P. ULTRAFILTER SMC 1.8 (US)
• 04046963845766: H.E.L.P. PRECIPITATE FILTER (US)
• 04046963816605: Dialog+® Patient Thera py Card Reader
• 04046963711177: EMPTY BAG FOR PRIMING SOLUTION FUTURA US
• 04046963711160: DIALYSING LINE FUTURA (US)
• 04046963711153: ARTERIAL LINE FUTURA (US)
• 04046963711139: H.E.L.P.® Plasmat ® Futura Treatment Kit
• 04046963686772: OPTION 7X10 ROLLER FOR BLOODPUMP SW9.XX
• 04046963686758: Option WAN BSL Dialog+ SW 9 (7102231)
• 04046963686734: Option Nexadia BSL SW 9.xx (7102230)
• 04046963686727: Dialog+® UltraPure Flu id Hemodialysis System Filter Kit
• 04046963686710: OPTION ACCU DIALOG + SW9.XX
• 04046963686697: Dialog+® Hemodialysis System Bicarbonate Cartridge Holder (BIC)
• 04046963686680: OPTION ABPM DIALOG+ SW9.XX
• 04039239070474: Emergency (standby) power supply (710524 4)
• 04039239070467: ABPM (7105226)
• 04039239070450: Central concentrate supply (7105196)
• 04039239070443: Bicarbonate cartridge (7105170)
• 04039239070436: Dialysis fluid filter (7105102)
• 04039239041733: DCI CABLE
• 04039239040859: ABPM Cuff (medium) (7102771)
• 04039239040743: ABPM Cuff (large) (7102380)
• 04039239040729: ABPM Cuff (small) (7102372)