| Primary Device ID | 37332414119325 |
| NIH Device Record Key | d86917ff-e1a0-497a-a1d2-db4d0ba2f75f |
| Commercial Distribution Discontinuation | 2017-07-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Dual Lumen Extended Length Catheter and GALT inser |
| Version Model Number | 115463 |
| Catalog Number | 115463 |
| Company DUNS | 132629788 |
| Company Name | GAMBRO UF SOLUTIONS, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414119324 [Primary] |
| GS1 | 37332414119325 [Package] Contains: 07332414119324 Package: CASE [5 Units] Discontinued: 2017-07-14 Not in Commercial Distribution |
| KDI | Dialyzer, high permeability with or without sealed dialysate system |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-12 |
| 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 | 2018-03-29The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic thera |
| 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 |