DEVICE: PHOENIX (07332414042035)

Device Identifier (DI) Information

PHOENIX
6023006700
Not in Commercial Distribution
103453
GAMBRO DASCO SPA
07332414042035
GS1
December 31, 2021
1
428788780 *Terms of Use
Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34994 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KDI Dialyzer, high permeability with or without sealed dialysate system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep dry, Fragile handle with care, Do not stack
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

003265a8-b239-4fba-8dfa-39bd9edc1f09
August 10, 2023
10
October 23, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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