Osmolarity High Control Solution

Primary DI: 10853539002055
Brand: Osmolarity High Control Solution
Company: Tearlab Corporation
Model: 100013
Published: 2024-01-05
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: true

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00853539002058	Primary	GS1	0
10853539002055	Unit of Use	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00853539002058	00853539002058	853539002058	0853539002058
10853539002055	10853539002055

GMDN Terms#

Term, Definition table
Term	Definition
Osmolality IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 155813749
Device count: 500
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
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 DI	Brand	Model	Catalog	Published
00853539002034	TearLab Osmolarity Test Card	100003		2025-08-28
00853539002041	Osmolarity Normal Control Solutions	100012		2024-01-05
00853539002058	Osmolarity High Control Solution	100013		2024-01-05
00853539002188	ScoutPro Osmolarity System	100094		2022-12-06
10853539002048	Osmolarity Normal Control Solutions	100012		2024-01-05
10853539002185	ScoutPro Osmolarity System	100094		2022-12-06