| Primary Device ID | 37332414069255 |
| NIH Device Record Key | b11d99eb-a4be-43a9-b1b4-ede34cd4ddce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRISMAFLEX SET |
| Version Model Number | HF1000 |
| Catalog Number | 107140 |
| Company DUNS | 393020474 |
| Company Name | GAMBRO INDUSTRIES |
| 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 | 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)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 | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414069254 [Primary] |
| GS1 | 37332414069255 [Package] Contains: 07332414069254 Package: CASE [4 Units] 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 | 4 |
| Public Version Date | 2020-01-30 |
| Device Publish Date | 2015-10-05 |
| 37332414090006 | The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the P |
| 37332414069316 | The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisM |
| 37332414069255 | The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system or with the PrisM |
| 37332414064557 | The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the P |
| 37332414064540 | The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the Pr |
| 50085412954108 | Disposable extracorporeal circuit |
| 50085412954078 | Disposable extracorporeal circuit |
| 50085412917691 | Disposable extracorporeal circuit |