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
CodeName
KYDStrip, Schirmer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYDStrip, SchirmerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24582495170142PackageGS110In Commercial Distribution
14582495170145PrimaryGS10
04582495170148Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2458249517014224582495170142
1458249517014514582495170145
04582495170148045824951701484582495170148

GMDN Terms#

Term, Definition table
TermDefinition
Schirmer tear test stripAn 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 DIBrandModelCatalogPublished
14582495170145SMTube1SMT142020-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668114841Color Bar Schirmer Tear TestKATENA PRODUCTS, INC.KYD2023-07-06
10841668114848Color Bar Schirmer Tear TestKATENA PRODUCTS, INC.KYD2023-07-06
14582495170145SMTubeECHO ELECTRICITY CO.,LTD.KYD2020-07-25
05060179470726Haag Streit UKHAAG-STREIT UK LIMITEDKYD2016-07-22