AccessGUDID - DEVICE: SMTube (14582495170145)

GUDID

Device Identifier (DI) Information

Brand Name: SMTube
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMT14
Company Name: ECHO ELECTRICITY CO.,LTD.

Primary DI Number: 14582495170145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 692575251 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37863	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYD	Strip, Schirmer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54d9601c-f76e-424b-a59d-f68e0abaa09c
Public Version Date: August 27, 2020
Public Version Number: 3
DI Record Publish Date: July 25, 2020