DEVICE: Membrane for E722 electrode (05700699420596)

Device Identifier (DI) Information

Membrane for E722 electrode
942-059
In Commercial Distribution
942-059
Radiometer Medical ApS
05700699420596
GS1

4
308667539 *Terms of Use
D722 K membrane box (4 units) for ABL7XX/8XX
CLOSE

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?
52892 Potassium (K+) IVD, kit, ion-selective electrode (ISE)
A collection of reagents and other associated materials intended to be used for the quantitative measurement of potassium (K+) in a clinical specimen, using an ion-selective electrode (ISE) method.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
GHS ASSAY, CARBOXYHEMOGLOBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
KQI ASSAY, FETAL HEMOGLOBIN
CGA GLUCOSE OXIDASE, GLUCOSE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CIG DIAZO COLORIMETRY, BILIRUBIN
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 32 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

0f0a8c24-1da3-4a54-a856-c55ea10c3caa
November 27, 2020
3
September 01, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 55700699420591 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
CLOSE