AccessGUDID - DEVICE: Adjustable Neoprene Chinstrap Small (00848530080068)

GUDID

Device Identifier (DI) Information

Brand Name: Adjustable Neoprene Chinstrap Small
Version or Model: CS003S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS003S
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530080068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Adjustable Neoprene Chinstrap (size small)

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:	No
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?
31254	Anaesthesia mask strap, reusable	A band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTK	Strap, Head, Gas Mask

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: 791e118d-0718-4cde-b724-4d9b223cd9ed
Public Version Date: August 29, 2018
Public Version Number: 1
DI Record Publish Date: July 29, 2018