GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)

GUDID 00195226000733

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Primary Device ID00195226000733
NIH Device Record Key782b207b-e05b-4612-8bb9-b316419be074
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)
Version Model Number00077445008
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100195226000733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

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.