AccessGUDID - DEVICE: GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST (08426950807810)

GUDID

Device Identifier (DI) Information

Brand Name: GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST
Version or Model: 00055445010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00055445010
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950807810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80bae6a9-926d-4dac-a089-5d94aec082f4
Public Version Date: August 04, 2023
Public Version Number: 8
DI Record Publish Date: January 24, 2018