DEVICE: REXEED (04537693003927)
Device Identifier (DI) Information
REXEED
25S
In Commercial Distribution
ASAHIKASEI MEDICAL MT K.K.
25S
In Commercial Distribution
ASAHIKASEI MEDICAL MT K.K.
Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
17a9d349-d87e-4c8f-abe6-3c633d2e67c6
March 29, 2018
2
November 01, 2015
March 29, 2018
2
November 01, 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 |
---|---|---|---|---|---|
14537693003924 | 12 | 04537693003927 | In Commercial Distribution |
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
[?]
847 641 5904
xx@xx.xx
xx@xx.xx