GEM ChemSTAT critPVP 1-4 00044001516

GUDID 08426951293858

GEM ChemSTAT critPVP1-4, 4 levels x 4 ampoules x 1.8 mL

INSTRUMENTATION LABORATORY COMPANY

Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control Multiple electrolyte IVD, control
Primary Device ID08426951293858
NIH Device Record Keyf3934e35-14b0-4017-8276-fab28e81c793
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM ChemSTAT critPVP 1-4
Version Model Number00044001516
Catalog Number00044001516
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count4
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426951293858 [Primary]
GS118426951293855 [Unit of Use]

FDA Product Code

GLKControl, Hematocrit

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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