FDA.reportPublic FDA data

OSMETTE III Probe

Primary DI
00850041049526
Brand
OSMETTE III Probe
Company
Precision Systems, Inc.
Model
2015
Catalog number
2015
Device description
OSMETTE III Probe
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
JJMOsmometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJMOsmometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041049526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041049526008500410495268500410495260850041049526

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, kit, freezing pointA collection of reagents and other associated materials intended to be used for the quantitative measurement of osmolality of a clinical specimen, using a freezing point method.

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

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
00850041049144Probe for Micro-OSMETTEPrecision Systems, Inc.JJM2023-10-14
00850041049168OSMETTE III with Barcode Reader, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049175Probe for Multi-OSMETTE Precision Systems, Inc.JJM2023-10-14
00850041049182Multi-OSMETTE, Extended Range, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049199OSMETTE XL, 105VAC, JapanPrecision Systems, Inc.JJM2023-10-14
00850041049212OSMETTE Sample Tubes, 2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049229OSMETTE Sample Tubes, 0.2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049236Micro-OSMETTE Sample Tubes, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049243OSMETTE XL, 105VAC, Japan, specialPrecision Systems, Inc.JJM2023-10-14
00850041049267OSMETTE Pipettor, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049281Clearview Disp Sample Tubes, 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049311CRYETTE Stir Wires, for 2 ml tubes, 4/pkPrecision Systems, Inc.JJM2023-10-14
00850041049328OSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049335Micro-OSMETTE Stir Wires for 50 ul samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049366OSMETTE III 10 ul Pipet Piston 2/pkPrecision Systems, Inc.JJM2023-10-14
00850041049373OSMETTE III Plunger Tip WirePrecision Systems, Inc.JJM2023-10-14
00850041049380OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
00850041049410OSMETTE Sample Tube Rack for 2.0 & 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049427Multi-OSMETTE Carousel, SparePrecision Systems, Inc.JJM2023-10-14
00850041049434Multi-OSMETTE Evaporation ShieldPrecision Systems, Inc.JJM2023-10-14
00850041049441OSMETTE Sample Tube Rack, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049489OSMETTE III Pipette Tips & CLEANETTEs, 1/M ea/pkPrecision Systems, Inc.JJM2023-10-14
00850041049502OSMETTE Probe 0.2 & 2.0 mlPrecision Systems, Inc.JJM2023-10-14
00850041049519Touch Micro-OSMETTE ProbePrecision Systems, Inc.JJM2023-10-14
00850041049533OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
0085004104954010 ul Pipettor for OSMETTE IIIPrecision Systems, Inc.JJM2023-10-14
00850041049557OSMETTE Pipette Tips 1000/pkg 30 - 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049564OSMETTE Printer RibbonPrecision Systems, Inc.JJM2023-10-14
00850041049571OSMETTE Bath Liquid, 250mlPrecision Systems, Inc.JJM2023-10-14
00850041049632Multi-OSMETTEPrecision Systems, Inc.JJM2023-10-14