| Primary Device ID | 57332414118919 |
| NIH Device Record Key | a0a974c3-7548-43aa-a14e-41fdd77207dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUTO EFFLUENT SET |
| Version Model Number | 115370 |
| Catalog Number | 115370 |
| Company DUNS | 132629788 |
| Company Name | GAMBRO UF SOLUTIONS, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com | |
| Phone | +1(800)525-2623 |
| Us.RENAL.Support.Co@vantive.com |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Total Volume | 6 Liter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414118914 [Primary] |
| GS1 | 57332414118919 [Package] Contains: 07332414118914 Package: CASE [8 Units] In Commercial Distribution |
| MON | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| 57332414118919 - AUTO EFFLUENT SET | 2025-08-26The Auto Effluent Accessory is indicated for use only with the PrisMax control unit in providing automatic effluent draining during Continuous Renal Replacement Therapy (CRRT). |
| 57332414118919 - AUTO EFFLUENT SET | 2025-08-26 The Auto Effluent Accessory is indicated for use only with the PrisMax control unit in providing automatic effluent draining dur |
| 57332414112269 - NA | 2018-10-29 A6001 5L Effluent Bag |
| 07332414112301 - Aquadex FlexFlow | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 27332414112367 - Dual Lumen Extended Length Catheter | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 37332414112371 - Blood Circuit Set | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 37332414112388 - Blood Circuit Set | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 37332414119325 - Dual Lumen Extended Length Catheter and GALT inser | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |