Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10 3MA005

GUDID 00816068020313

Calibration standards are used to calibrate and/or check the performance of customer osmometers.

ADVANCED INSTRUMENTS, INC.

Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator Osmolality IVD, calibrator
Primary Device ID00816068020313
NIH Device Record Keyb9398094-7084-42fb-916d-409c3a407adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10
Version Model Number3MA005
Catalog Number3MA005
Company DUNS125006353
Company NameADVANCED INSTRUMENTS, INC.
Device Count10
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com
Phone+17813209000
EmailOrders@aicompanies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816068020313 [Unit of Use]
GS110816068020310 [Primary]

FDA Product Code

JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

Devices Manufactured by ADVANCED INSTRUMENTS, INC.

00816068020535 - Advanced Instruments RBC Reagent Filtration Kit2021-05-31 The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance crite
00816068020290 - Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 82020-09-29 Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used
00816068020351 - Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 92020-09-29 Protinol protein-based osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls m
00816068020481 - Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 102020-09-29 The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and f
00816068020504 - Advanced Instruments Ease-Eject 20-Microliter Sampler2020-09-29 Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or
00816068020542 - Advanced Instruments Osmo1® Single-Sample Micro-Osmometer2020-09-29 With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of
00816068020559 - Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer2020-09-29 Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel desig
00816068020566 - Advanced Instruments 30 µL Pipet2020-09-29 Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers

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