AccessGUDID - DEVICE: RUSCH (14026704641533)

GUDID

Device Identifier (DI) Information

Brand Name: RUSCH
Version or Model: IPN049976
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9912001
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704641533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704544677

Device Description: HEAD HARNESS - ADULT

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):	Yes
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?
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: 1e7eb85f-8b1c-4682-958e-1b9d870b12a2
Public Version Date: July 19, 2023
Public Version Number: 3
DI Record Publish Date: April 24, 2019