FDA.reportPublic FDA data

Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10

Primary DI
00816068020306
Brand
Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10
Company
ADVANCED INSTRUMENTS, INC.
Model
3MA200
Catalog number
3MA200
Device description
Calibration standards are used to calibrate and/or check the performance of customer osmometers.
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, OsmolalityClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816068020303PrimaryGS10
00816068020306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081606802030310816068020303
00816068020306008160680203068160680203060816068020306

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17813209000Orders@aicompanies.com

Regulatory Flags#

DUNS number
125006353
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816068020566Advanced Instruments 30 µL Pipet2228202228202020-09-21
00816068020795Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes2028252028252020-09-21
00816068020825Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 5003LA8253LA8252020-09-21
00816068020979Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 103MA0033MA0032020-09-21
00816068020269Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 103LA0293LA0292020-09-21
00816068020313Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0053MA0052020-09-21
00816068020368Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 103MA0293MA0292020-09-21
00816068020375Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0853MA0852020-09-21
00816068020436Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0113LA0112020-09-21
00816068020443Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA1513LA1512020-09-21
00816068020450Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0513LA0512020-09-21
00816068020467Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0913LA0912020-09-21
00816068020474Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA2013LA2012020-09-21
00816068020603Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 5002002232002232020-09-21
00816068020740Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA3013LA3012020-09-21
00816068020757Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0003MA0002020-09-21
00816068020764Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0203MA0202020-09-21
00816068020771Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0403MA0402020-09-21
00816068020788Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA1003MA1002020-09-21
00816068020993Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 103MA4003MA4002020-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850041049014Precision Systems 100 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049021Precision Systems 200 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049038Precision Systems 300 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049045Precision Systems 400 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049052Precision Systems 500 mOsm Osmometry Standard, 125 mL bottlePrecision Systems, Inc.JMZ2023-10-14
00850041049069Precision Systems 600 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049076Precision Systems 700 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049083Precision Systems 800 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049090Precision Systems 900 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049106Precision Systems 1000 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049113Precision Systems 1100 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049120Precision Systems 1200 mOsm Osmometry Standard, 250 mL bottlePrecision Systems, Inc.JMZ2023-10-14
00850041049137Precision Systems 1300 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049151Precision Systems 1500 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049205Precision Systems 2000 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049250Precision Systems 2500 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049304Precision Systems 3000 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-10-14
00850041049588Precision Systems CON-TROL 100, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049595Precision Systems CON-TROL 290, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049601Precision Systems CON-TROL 500, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049618Precision Systems CON-TROL 1500, 5 ml ampules, 12/pkPrecision Systems, Inc.JMZ2023-10-14
00850041049625Precision Systems CON-TROL Cal Pack, 4 each: 100, 500 & 1500 mOsm 5 ml ampulesPrecision Systems, Inc.JMZ2023-10-14
00850041049007Precision Systems 0 mOsm Osmometry StandardPrecision Systems, Inc.JMZ2023-09-29
10816068020266Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020303Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020310Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020365Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020372Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020433Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21
10816068020440Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21