International Medical Devices Database

Manufacturer Address
Gambro Renal Products Inc, 1101 Jeter Ave, Opelika AL 36801-3885
Manufacturer Parent Company (2017)
Baxter International
Source
USFDA
2 Events
- Recall of Device Recall Polyflux Revaclear
- Recall of Device Recall Polyflux Revaclear

2 devices in the database

Device Recall Polyflux Revaclear

Model / Serial
Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Product Description
Polyflux Revaclear Max Dialyzer, Model Number 110634. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

Device Recall Polyflux Revaclear

Model / Serial
Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Product Description
Polyflux Revaclear Dialyzer, Model Number 110633. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

2 manufacturers with a similar name

Learn more about the data here

Gambro Renal Products Inc.

Manufacturer Parent Company (2017)
Baxter International
Source
AEMPSVFOI

Gambro Renal Products Inc.

Manufacturer Parent Company (2017)
Baxter International
Source
BAM

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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