GEM ChemSTAT CVP 1 00044000115

GUDID 08426951293742

GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08426951293742
NIH Device Record Key99948619-5372-4b7b-b88a-e5944540847e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM ChemSTAT CVP 1
Version Model Number00044000115
Catalog Number00044000115
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone+1 800-678-0710
Emailtechsupport@ilww.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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426951293742 [Primary]
GS118426951293749 [Unit of Use]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-04
Device Publish Date2019-06-26

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00195226000542 - ACL TOP 770s2024-05-23 ACL TOP 770s
00195226000559 - ACL TOP 5702024-05-23 ACL TOP 570
00195226000566 - ACL TOP 3702024-05-23 ACL TOP 370

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