FDA.report

GEM Premier 3500

Primary DI
08426950793328
Brand
GEM Premier 3500
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00026000000
Catalog number
00026000000
Device description
GEM Premier 3500
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Product Code Classifications

CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950793328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950793328084269507933288426950793328

GMDN Terms

TermDefinition
Blood gas/haemoximetry analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags

DUNS number
557223252
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00195226000627GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)000774450102023-10-02
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00195226000696GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)000774450102023-10-02
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00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

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00195226000726GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
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