GEM CVP (Calibration Valuation Product) 1 with CO-OX 00025000115

GUDID 08426950440680

GEM CVP (Calibration Valuation Product) 1 with CO-OX

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08426950440680
NIH Device Record Keyc751c647-d0f4-4d7e-b3af-e8a2e6bc1e14
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM CVP (Calibration Valuation Product) 1 with CO-OX
Version Model Number00025000115
Catalog Number00025000115
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count10
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.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 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *CVP 1 and 2: Unopened ampules are stored at 2-8° C, or up to 8 months at room temperature (15- 25° C), CVP 3 and 4: Unopened ampules stored at room temperature 15-25° C. DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950440680 [Primary]
GS118426950440687 [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 Date2021-07-08
Device Publish Date2016-09-23

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