FDA.reportPublic FDA data

Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle

Primary DI
00850041049052
Brand
Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle
Company
Precision Systems, Inc.
Model
2105
Catalog number
2105
Device description
Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle
Published
2023-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850041049052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041049052008500410490528500410490520850041049052

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
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-655-7010precisionsystems@msn.com

Regulatory Flags#

DUNS number
001001676
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041049212OSMETTE Sample Tubes, 2 ml, 12/pk202120212023-10-14
00850041049229OSMETTE Sample Tubes, 0.2 ml, 12/pk202220222023-10-14
00850041049236Micro-OSMETTE Sample Tubes, 50 ul202320232023-10-14
00850041049281Clearview Disp Sample Tubes, 0.2 ml202820282023-10-14
00850041049380OSMETTE Sample Tubes, 30 ul203820382023-10-14
00850041049489OSMETTE III Pipette Tips & CLEANETTEs, 1/M ea/pk204820482023-10-14
00850041049533OSMETTE Sample Tubes, 30 ul202020202023-10-14
00850041049014Precision Systems 100 mOsm Osmometry Standard210121012023-10-14
00850041049021Precision Systems 200 mOsm Osmometry Standard210221022023-10-14
00850041049038Precision Systems 300 mOsm Osmometry Standard210321032023-10-14
00850041049045Precision Systems 400 mOsm Osmometry Standard210421042023-10-14
00850041049069Precision Systems 600 mOsm Osmometry Standard210621062023-10-14
00850041049076Precision Systems 700 mOsm Osmometry Standard210721072023-10-14
00850041049083Precision Systems 800 mOsm Osmometry Standard210821082023-10-14
00850041049090Precision Systems 900 mOsm Osmometry Standard210921092023-10-14
00850041049106Precision Systems 1000 mOsm Osmometry Standard211021102023-10-14
00850041049113Precision Systems 1100 mOsm Osmometry Standard211121112023-10-14
00850041049120Precision Systems 1200 mOsm Osmometry Standard, 250 mL bottle211221122023-10-14
00850041049137Precision Systems 1300 mOsm Osmometry Standard211321132023-10-14
00850041049144Probe for Micro-OSMETTE201420142023-10-14

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
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
10816068020457Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLCJMZ2020-09-21