GEM Hematocrit Evaluator 2 00025000105

GUDID 08426950573678

GEM Hematocrit Evaluator 2

INSTRUMENTATION LABORATORY COMPANY

Red blood cell count IVD, control
Primary Device ID08426950573678
NIH Device Record Key734b7b93-8e2a-422c-a056-6d5e0332d4b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Hematocrit Evaluator 2
Version Model Number00025000105
Catalog Number00025000105
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
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 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable until the expiration date shown on the label when stored at room temperature (15- 25°C), providing storage does not exceed the expiration date. DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950573678 [Primary]
GS118426950573675 [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

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

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