GEM CVP (Calibration Validation Product) Level 3 00024001813

GUDID 08426950358756

GEM CVP (Calibration Validation Product) Level 3

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08426950358756
NIH Device Record Keye52cb633-442c-45e1-8ab1-44760de5952a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM CVP (Calibration Validation Product) Level 3
Version Model Number00024001813
Catalog Number00024001813
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count20
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 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampules are stored at 2-8°C, or up to 12 months at room temperature (20-28°C), providing storage does not exceed the expiration date. DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950358756 [Primary]
GS118426950358753 [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

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

08430793242998 - HEMOSIL RIVAROXABAN CONTROLS2024-07-30 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vial
08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi
00195226001129 - HemosIL Chromogenic Factor IX2024-07-17 HemosIL Chromogenic Factor IX
00195226000528 - ACL TOP 7702024-05-23 ACL TOP 770
00195226000535 - ACL TOP 770 LAS2024-05-23 ACL TOP 770 LAS
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.