AccessGUDID - DEVICE: ASIA MED (04251282509255)

GUDID

Device Identifier (DI) Information

Brand Name: ASIA MED
Version or Model: TAPE ORANGE, 5M X 5CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A006720
Company Name: asia-med GmbH

Primary DI Number: 04251282509255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333450844 *Terms of Use

Device Description: asia-med Kinesiology Tape - Orange: made of cotton fabric with a medical grade acrylic adhesive applied in a wave pattern. Flexibility in longitudinal direction: approx. 60% (1:1,6)|Size: length 5 m, width 5 cm|Color: Orange|Sales unit: 1 roll

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?
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 8 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 5 Centimeter
Length: 5 Meter

Device Record Status

Public Device Record Key: 7db878ad-2427-4d79-bc1a-88e0e734ba09
Public Version Date: October 23, 2019
Public Version Number: 2
DI Record Publish Date: July 31, 2018