Urine Standard, 100 Na 100K 00003510000

GUDID 08426950010906

Urine Standard, 100 Na 100K

INSTRUMENTATION LABORATORY COMPANY

Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator
Primary Device ID08426950010906
NIH Device Record Key79ad6931-eb6a-4808-9ee1-e7e5f674ce63
Commercial Distribution Discontinuation2019-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameUrine Standard, 100 Na 100K
Version Model Number00003510000
Catalog Number00003510000
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 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

Phone800-678-0710
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@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 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950010906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJOFLAME EMISSION PHOTOMETER FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-17
Device Publish Date2016-09-23

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

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00195226000627 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 T
00195226000634 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 T
00195226000658 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 T
00195226000665 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Te
00195226000672 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
00195226000689 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
00195226000696 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2

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