B.BRAUN 7102868

GUDID 04046964738388

CCS CONNECTOR FOR 3 CONCENTRATES

B.Braun Avitum AG

Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional

• Primary Device ID: 04046964738388
• NIH Device Record Key: 4fbb0a8f-cd95-4ba8-b35f-22d2460f2552
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.BRAUN
• Version Model Number: 7102868
• Catalog Number: 7102868
• Company DUNS: 343689704
• Company Name: B.Braun Avitum AG
• 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: false
• Lot Batch: false
• Serial Number: false
• 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 Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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	04046964738388 [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)