OPTIMOLE™ Osmolality Standard, 100 mmol/kg, 60x.4mL

GUDID 03661540301483

ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.

ELITECHGROUP INC.

Osmolality IVD, calibrator
Primary Device ID03661540301483
NIH Device Record Key0a10bae5-cfe6-4e9b-a6da-95d8df1267b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTIMOLE™ Osmolality Standard, 100 mmol/kg, 60x.4mL
Version Model NumberOA-010
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com
Phone1-800-453-2725
Emailservice_ebs@elitechgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540301483 [Primary]

FDA Product Code

JISCalibrator, Primary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-01
Device Publish Date2021-02-19

Devices Manufactured by ELITECHGROUP INC.

03661540300035 - Microsed-System® Automated ESR Analyzer2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de
03661540300042 - Mix-Rate® X20 Automated ESR Analyzer2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de
03661540300202 - Monosed® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300219 - Monosed® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300257 - Excyte® ESR Vacuum Tubes, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300264 - Excyte® ESR Vacuum Tube, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
03661540300271 - Excyte® ESR Vacuum Tube, Carton2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.