baxter.comMARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
GAMBRO RENAL PRODUCTS, INC.
Gambro Renal Products, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006552611 | 3006552611 | Gambro Renal Products, Inc. | 1 | N | 2020-04-25 | 1101 Jeter Avenue Opelika AL US 36801 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07332414101695 | POLYFLUX REVACLEAR - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414101701 | POLYFLUX REVACLEAR MAX - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414123055 | REVACLEAR - Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414124076 | REVACLEAR - Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis | +1(800)933-0303 | MEDINFO_MEDPRODUCTS@BAXTER.COM |
| 37332414101696 | POLYFLUX REVACLEAR - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 87888 | 1142140372 | K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | KDI | 2013-05-02 |
| 87888 | 1312424068 | K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | KDI | 2007-09-07 |
| 87888 | 2027047716 | K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE | KDI | 2006-04-24 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KDI | 3 | 2013-05-02 |
PMN#
PRISMAFLEX SYSTEM 7.10
GAMBRO RENAL PRODUCTS, INC.
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
GAMBRO RENAL PRODUCTS, INC.
MOLECULAR ADSORBENT RECIRCULATING(MARS)
GAMBRO RENAL PRODUCTS, INC.
PRISMAFLEX
GAMBRO RENAL PRODUCTS, INC.
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
GAMBRO RENAL PRODUCTS, INC.
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
GAMBRO RENAL PRODUCTS, INC.
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
GAMBRO RENAL PRODUCTS, INC.
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
GAMBRO RENAL PRODUCTS, INC.
PRISMAFLEX M150 SET
GAMBRO RENAL PRODUCTS, INC.
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
GAMBRO RENAL PRODUCTS, INC.
PRISMA M10 PRE SET
GAMBRO RENAL PRODUCTS, INC.
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
GAMBRO RENAL PRODUCTS, INC.
GUDID#
REVACLEAR - Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis
2017-02-08
REVACLEAR - Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis
2018-01-15
POLYFLUX REVACLEAR - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
2015-10-07
POLYFLUX REVACLEAR MAX - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
2015-10-07
POLYFLUX REVACLEAR - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
2015-10-07
POLYFLUX REVACLEAR MAX - Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
2015-10-07
REVACLEAR - Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis
2017-02-08
REVACLEAR - Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis
2018-01-15