REVACLEAR 114746L
GUDID 37332414124077
Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis
GAMBRO RENAL PRODUCTS, INC.
Hollow-fibre haemodialysis dialyser, single-use| Primary Device ID | 37332414124077 |
| NIH Device Record Key | 3a794490-7924-4d88-ab58-07758b60200d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REVACLEAR |
| Version Model Number | 400 |
| Catalog Number | 114746L |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414124076 [Primary] |
| GS1 | 37332414124077 [Package] Contains: 07332414124076 Package: CASE [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130039
FDA Product Code
| KDI | Dialyzer, high permeability with or without sealed dialysate system |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-15 |
On-Brand Devices [REVACLEAR]
| 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 |
Trademark Results [REVACLEAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVACLEAR 85768855 4424307 Live/Registered |
GAMBRO LUNDIA AB 2012-11-01 |
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