FDA.reportPublic FDA data

OSMETTE XL, 105VAC, Japan

Primary DI
00850041049199
Brand
OSMETTE XL, 105VAC, Japan
Company
Precision Systems, Inc.
Model
5007J
Catalog number
5007J
Device description
Precision Systems OSMETTE XL osmometer, 105VAC, Japan
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
00850041049199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041049199008500410491998500410491990850041049199

GMDN Terms#

Term, Definition table
TermDefinition
Osmometric analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum, tears, sweat) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)].

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
Serial number
true
Manufacturing 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
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
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
00850041049526OSMETTE III 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