AccessGUDID - DEVICE: HARNESS LARGE/MEDIUM FOR CPAP FACE MASK. (05030267063963)

GUDID

Device Identifier (DI) Information

Brand Name: HARNESS LARGE/MEDIUM FOR CPAP FACE MASK.
Version or Model: 2224000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersurgical Incorporated

Primary DI Number: 05030267063963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785952607 *Terms of Use

Device Description: HARNESS LARGE/MEDIUM FOR CPAP FACE MASK.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
60882	Anaesthesia mask strap, single-use	A non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use 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: f91ec84b-79c8-4a2c-9641-e53ffbfe9358
Public Version Date: February 11, 2025
Public Version Number: 2
DI Record Publish Date: June 15, 2023