FDA.reportPublic FDA data

Precision Systems CON-TROL 100, 5 ml ampules, 12/pk

Primary DI
00850041049588
Brand
Precision Systems CON-TROL 100, 5 ml ampules, 12/pk
Company
Precision Systems, Inc.
Model
2201
Catalog number
2201
Device description
Precision Systems CON-TROL 100, 5 ml ampules, 12/pk
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
00850041049588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041049588008500410495888500410495880850041049588

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
00850041049052Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle210521052023-10-14
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

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
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