FDA.reportPublic FDA data

GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL

Primary DI
04260341780740
Brand
GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL
Company
G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
Model
30.9.0850
Catalog number
30.9.0850
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260341780580PrimaryGS10
04260341780740Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260341780580042603417805804260341780580
04260341780740042603417807404260341780740

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
319441788
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04260341780597GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL30.9.200030.9.20002021-05-07
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
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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