Home GUDID 24582495170142
SMTube
Primary DI 24582495170142
Brand SMTube
Company ECHO ELECTRICITY CO.,LTD.
Model 1
Catalog number SMT14
Device description Strip Meniscometry Tube, known as SMTube evaluates tear meniscus volume in 5 seconds. Catalog Number SMT14 is made for FDA compliance packaging for US Market.
Published 2020-07-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KYD Strip, Schirmer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KYD Strip, Schirmer Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 24582495170142 Package GS1 10 In Commercial Distribution 14582495170145 Primary GS1 0 04582495170148 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 24582495170142 24582495170142 14582495170145 14582495170145 04582495170148 04582495170148 4582495170148
GMDN Terms# Term, Definition table Term Definition Schirmer tear test strip An ophthalmic device in the form of a small absorbent strip, made of filter paper or similar material, that is manually inserted under the patient's lower eyelid for a period of time to stimulate and evaluate the formation of tears. Commonly known as the Schirmer's test (ST), the device is used to provide a rapid lacrimal assessment for tearflow or tear volume. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 692575251 Device count 50 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 true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 14582495170145 SMTube 1 SMT14 2020-07-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841668114841 Color Bar Schirmer Tear Test KATENA PRODUCTS, INC. KYD 2023-07-06 10841668114848 Color Bar Schirmer Tear Test KATENA PRODUCTS, INC. KYD 2023-07-06 14582495170145 SMTube ECHO ELECTRICITY CO.,LTD. KYD 2020-07-25 05060179470726 Haag Streit UK HAAG-STREIT UK LIMITED KYD 2016-07-22