GEM CVP (Calibration Validation Product) Level 4 00024001814

GUDID 08426950358763

GEM CVP (Calibration Validation Product) Level 4

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08426950358763
NIH Device Record Key2f3c7ca5-e277-4c87-8bbe-6664bb5c2f49
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM CVP (Calibration Validation Product) Level 4
Version Model Number00024001814
Catalog Number00024001814
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count20
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 Numberfalse
Manufacturing Datefalse
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.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

Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950358763 [Primary]
GS118426950358760 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-09
Device Publish Date2016-09-23

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