GEM CVP (Calibration Valuation Product) 4 Hematocrit 00025000140

GUDID 08426950446248

GEM CVP (Calibration Valuation Product) 4 Hematocrit

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08426950446248
NIH Device Record Keyaf8a4fe2-2e27-4238-b180-96af34410f34
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM CVP (Calibration Valuation Product) 4 Hematocrit
Version Model Number00025000140
Catalog Number00025000140
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

Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
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@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 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.
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
GS108426950446248 [Primary]
GS118426950446245 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GLKCONTROL, HEMATOCRIT

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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00195226000542 - ACL TOP 770s2024-05-23 ACL TOP 770s
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00195226000566 - ACL TOP 3702024-05-23 ACL TOP 370

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