AccessGUDID - DEVICE: CINCH (00842071130930)

GUDID

Device Identifier (DI) Information

Brand Name: CINCH
Version or Model: CINCH930L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CINCH930L, CINCH930L-10, CINCH930L-50
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071130930
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: AMT CINCH Tube Securement Device - Large

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96e45969-1ef9-43e7-99c8-95ca1b63bf4a
Public Version Date: April 07, 2025
Public Version Number: 3
DI Record Publish Date: November 04, 2020