TearCheck T

Basic Information

• Brand Name: TearCheck T
• Primary DI: 03662824003048
• Version / Model: N040US000A08A
• Company Name: E-SWIN
• Labeler DUNS: 267700713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-06
• Public Version: 1
• Public Version Date: 2023-03-14
• Public Version Status: New
• Public Device Record Key: e06bd019-e0bc-4ce7-8d6e-664736e69097

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	886.1350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45734	Corneal topography system analyser	A mains electricity (AC-powered) ophthalmic device used to measure the curvature and concentricity of the anterior corneal surface. It is typically a dedicated videokeratoscope that uses Placido imaging (involves a disk with concentric white and black rings) to provide keratometric and topographic measurements and images. It will typically output to a dedicated computer workstation or external computer with installed dedicated application software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03662824003048	GS1

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 76 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -5 – 65 Degrees Celsius