DEVICE: Polyflux Revaclear (07332414101695)
Device Identifier (DI) Information
Polyflux Revaclear
110633
In Commercial Distribution
110633
GAMBRO RENAL PRODUCTS, INC.
110633
In Commercial Distribution
110633
GAMBRO RENAL PRODUCTS, INC.
Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Hollow-fibre haemodialysis dialyser, single-use | A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KDI | Dialyzer, high permeability with or without sealed dialysate system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K072232 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: less than 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b6d6c4cb-ccf0-4e52-b672-7bca10a7472e
July 06, 2018
3
October 07, 2015
July 06, 2018
3
October 07, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
37332414101696 | 24 | 07332414101695 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com