NorLab

Primary DI: 00860009621916
Brand: NorLab
Company: Norco, Inc.
Model: Medical Blood Gas
Device description: For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
Published: 2022-12-12
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
Code	Name
LCH	Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
LCH	Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical	Clinical Chemistry	1

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K904163	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K904163	000	CLINICAL BLOOD GAS MIXTURES	Norco, Inc.	1990-11-01	LCH

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860009621916	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860009621916	00860009621916	860009621916	0860009621916

GMDN Terms#

Term, Definition table
Term	Definition
Multiple blood gas analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Regulatory Flags#

DUNS number: 043694645
Device count: 1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00860009621909	NorLab	Medical Calibration Gas		2022-12-12
00860009621923	NorLab	Medical Laser Gas		2022-12-12