Dialog+® 710200S
GUDID 04046964285608
Dialog + 120 V DF+Adimea+WAN-BSL+BIC
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 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 | 04046964285608 |
| NIH Device Record Key | 9f119f16-1a87-40c0-b0ea-97bfd7d9c051 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dialog+® |
| Version Model Number | 710200S |
| Catalog Number | 710200S |
| 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 | 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 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| 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 Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964285608 [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 | 4 |
| Public Version Date | 2021-09-14 |
| Device Publish Date | 2015-08-09 |
On-Brand Devices [Dialog+®]
| 04046964285615 | Dialog + 120 V DF+Adimea+WAN-BSL |
| 04046964285608 | Dialog + 120 V DF+Adimea+WAN-BSL+BIC |
| 04046963686345 | Dialog+® Hemodialysis System with BIC Holder for Bicarbonate Cartridge |
| 04046963686338 | Dialog+® Evolution Hemodialysis System |
Trademark Results [Dialog+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIALOG+ 76567692 3097064 Live/Registered |
B. BRAUN AVITUM AG 2003-12-12 |
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