FDA.reportPublic FDA data

GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL

Primary DI
04260341780597
Brand
GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL
Company
G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
Model
30.9.2000
Catalog number
30.9.2000
Device description
Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel.
Published
2021-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032608000GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB2003-10-21JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260341780597PrimaryGS10
04260341780757Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260341780597042603417805974260341780597
04260341780757042603417807574260341780757

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 Temperature5 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+493078095880info@gonotec.com

Regulatory Flags#

DUNS number
319441788
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260341780566GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mL30.9.010030.9.01002021-05-07
04260341780573GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL30.9.050030.9.05002021-05-07
04260341780580GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL30.9.085030.9.08502021-05-07
04260341780603GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml30.9.029030.9.02902021-05-07
04260341780559GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O - 10 x 1mL30.9.002030.9.00202021-05-07
04260341780726GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mL30.9.010030.9.01002021-05-07
04260341780733GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL30.9.050030.9.05002021-05-07
04260341780740GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL30.9.085030.9.08502021-05-07
04260341780757GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL30.9.200030.9.20002021-05-07
04260341780764GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml30.9.029030.9.02902021-05-07

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