Primary Device ID | 37332414123056 |
NIH Device Record Key | ebdae05d-c755-4ed6-bb61-0692b9c6270f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | REVACLEAR |
Version Model Number | 300 |
Catalog Number | 114745L |
Company DUNS | 929768682 |
Company Name | GAMBRO RENAL PRODUCTS, INC. |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07332414123055 [Primary] |
GS1 | 37332414123056 [Package] Contains: 07332414123055 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 | 2017-02-08 |
37332414124077 | Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodial |
37332414123056 | Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failu |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REVACLEAR 85768855 4424307 Live/Registered |
GAMBRO LUNDIA AB 2012-11-01 |