DEVICE: PHOENIX (07332414042035)
Device Identifier (DI) Information
PHOENIX
6023006700
In Commercial Distribution
103453
GAMBRO DASCO SPA
6023006700
In Commercial Distribution
103453
GAMBRO DASCO SPA
Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Haemodialysis system dialysate delivery unit | An electrically-powered integral unit of a haemodialysis system that prepare and delivers the haemodialysis dialysate solution to the haemodialysis dialyser where it is used in the treatment of the patient (one patient only). It monitors and controls such indicators as temperature, conductivity, flow rate, and pressure. |
FDA Product Code
[?]Product Code | Product Code Name |
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KDI | Dialyzer, high permeability with or without sealed dialysate system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K070643 | 000 |
K103832 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Special Storage Condition, Specify: Keep dry, Fragile handle with care, Do not stack |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
003265a8-b239-4fba-8dfa-39bd9edc1f09
July 06, 2018
3
October 23, 2015
July 06, 2018
3
October 23, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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