GEM Premier 5000 PAK BG ISE COOX (300 TEST) 00055430008XC

GUDID 08426951027293

GEM 5000 BG ISE COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Primary Device ID08426951027293
NIH Device Record Key547ed99a-a62b-44a0-aacf-dbecdb0efe34
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Premier 5000 PAK BG ISE COOX (300 TEST)
Version Model Number00055430008XC
Catalog Number00055430008XC
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426951027293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-12
Device Publish Date2017-03-29

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