Primary Device ID | 37332414114917 |
NIH Device Record Key | 718d158c-bbe1-4152-9e97-5fa2457287aa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Revaclear |
Version Model Number | 300 |
Catalog Number | 114745 |
Company DUNS | 316150549 |
Company Name | Gambro Dialysatoren GmbH |
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 | 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 |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Area/Surface Area | 1.4 Square meter |
Handling 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 |
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 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07332414114916 [Primary] |
GS1 | 37332414114917 [Package] Contains: 07332414114916 Package: CASE [24 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 | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-12 |
37332414114924 | Revaclear 300-400 are indicated for the tretment of chronic and acute renal failure by hemodialy |
37332414114917 | Revaclear 300-400 are indicated for the tretment of chronic and acute renal failure by hemodialy |
37332414126200 | Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodi |
37332414126194 | Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodi |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REVACLEAR 85768855 4424307 Live/Registered |
GAMBRO LUNDIA AB 2012-11-01 |