DEVICE: GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST (08426950807636)
Device Identifier (DI) Information
GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST
00055407510
In Commercial Distribution
00055407510
INSTRUMENTATION LABORATORY COMPANY
00055407510
In Commercial Distribution
00055407510
INSTRUMENTATION LABORATORY COMPANY
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
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? |
---|---|---|---|---|
52858 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
GHS | Assay, Carboxyhemoglobin |
JFP | Electrode, Ion Specific, Calcium |
JGS | Electrode, Ion Specific, Sodium |
CGA | Glucose Oxidase, Glucose |
KHP | Acid, Lactic, Enzymatic Method |
GLY | Oximeter To Measure Hemoglobin |
CEM | Electrode, Ion Specific, Potassium |
CGZ | Electrode, Ion-Specific, Chloride |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160225 | 000 |
K160402 | 000 |
K160415 | 000 |
K173403 | 000 |
K203790 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Special Storage Condition, Specify: STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5e5f8a00-fdd2-4ef8-bf2d-651b8aeae365
August 04, 2023
8
January 24, 2018
August 04, 2023
8
January 24, 2018
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 |
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
[?]
1-800-678-0710
techsupport.na@werfen.com
techsupport.na@werfen.com