Diapact® 7106510
GUDID 04039239041252
Diapact® CRRT System
B.Braun Avitum AG
Haemodialysis system, institutional| Primary Device ID | 04039239041252 |
| NIH Device Record Key | 28466223-9804-424c-b7da-ab03537b3673 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diapact® |
| Version Model Number | 7106510 |
| Catalog Number | 7106510 |
| 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04039239041252 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K973322
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 |
Devices Manufactured by B.Braun Avitum AG
| 04046955659616 - Diacap® | 2024-07-26 Diacap Pro 13H |
| 04046955659630 - Diacap® | 2024-07-26 Diacap Pro 16H |
| 04046955659654 - Diacap® | 2024-07-26 Diacap Pro 19H |
| 04046955725151 - AQUAbase® | 2023-10-17 AQUAbase® nX HT 250 Reverse Osmosis System |
| 04046955725168 - AQUAbase® | 2023-10-17 AQUAbase® nX HT 500 Reverse Osmosis System |
| 04046955725175 - AQUAbase® | 2023-10-17 AQUAbase nX 750HT (60Hz/208-220V) |
| 04046963178109 - Diacap® | 2022-11-29 DIACAP ULTRA DF FILTER CA & US |
| 04046964320026 - Diacap® | 2022-09-30 Diacap Polysulfone® HI PS 18 Dialyzer |
Trademark Results [Diapact]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIAPACT 76066406 2463923 Live/Registered |
B. Braun Medical, Inc. 2000-06-08 |
 DIAPACT 75858525 2514044 Dead/Cancelled |
B. BRAUN AVITUM AG 1999-11-23 |
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