Primary Device ID | 50085412954078 |
NIH Device Record Key | 53d04d30-3f97-4171-a131-fa1bf3e34081 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PRISMAFLEX SET |
Version Model Number | 107636US |
Catalog Number | 107636US |
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 | |
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 |
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 | 00085412954073 [Primary] |
GS1 | 50085412954078 [Package] Contains: 00085412954073 Package: CA [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 | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-30 |
Device Publish Date | 2022-11-22 |
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 |