AccessGUDID - DEVICE: GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST (08426950807568)

GUDID

Device Identifier (DI) Information

Brand Name: GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST
Version or Model: 00055360005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00055360005
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950807568
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, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 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
MQM	Bilirubin (Total And Unbound) In The Neonate Test System
GLY	Oximeter To Measure Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
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
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

Public Device Record Key: ff8bb5f3-801e-464a-b8af-2dd57e37cf55
Public Version Date: August 04, 2023
Public Version Number: 8
DI Record Publish Date: January 24, 2018