Polyflux 104333
GUDID 37332414041473
The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse o
Gambro Dialysatoren GmbH
Hollow-fibre haemodialysis dialyser, reusable| Primary Device ID | 37332414041473 |
| NIH Device Record Key | 35a91a5b-3a97-453b-85bd-824216dc13ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polyflux |
| Version Model Number | 8LR |
| Catalog Number | 104333 |
| 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 | false |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414041472 [Primary] |
| GS1 | 37332414041473 [Package] Contains: 07332414041472 Package: CASE [16 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043342
FDA Product Code
| MSF | HEMODIALYZER, RE-USE, HIGH FLUX |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
[37332414041473]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-12 |
On-Brand Devices [Polyflux]
| 37332414048199 | The polyflux H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the |
| 37332414048182 | The Polyflux L is intended for use in haemodialysis for the treatment of chronic or acute renal |
| 37332414047109 | The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal |
| 37332414041473 | The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal |
| 37332414041466 | The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal |
| 37332414037933 | The polyflux H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the |
| 37332414037926 | The polyflux H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the |
| 37332414036424 | The Polyflux L is intended for use in haemodialysis for the treatment of chronic or acute renal |
| 37332414036417 | The POLYflux 17L is intended for hemodialysis in the treatment of chronic or acute renal failure |
| 37332414036387 | the Polyflux 6H is intended for chronic and acute applications in haemodialysis haemofiltration |
| 37332414036141 | Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal fail |
| 37332414031788 | Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal fail |
| 37332414031771 | Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal fail |
Trademark Results [Polyflux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLYFLUX 86121306 not registered Dead/Abandoned |
VeroLube, Inc. 2013-11-18 |
 POLYFLUX 78751582 not registered Dead/Abandoned |
PetroTex Hydrocarbons, LLC 2005-11-10 |
 POLYFLUX 78427122 not registered Dead/Abandoned |
ASPEN PETROLEUM GROUP, LLC 2004-05-28 |
 POLYFLUX 76215092 2691518 Live/Registered |
Gambro Lundia AB 2001-02-23 |
 POLYFLUX 72416670 0970745 Dead/Expired |
WELD MOLD COMPANY 1972-02-25 |
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