AccessGUDID - DEVICE: Hauge ll Airway Conscious Sedation Kit (00709078011573)

GUDID

Device Identifier (DI) Information

Brand Name: Hauge ll Airway Conscious Sedation Kit
Version or Model: 6595
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078011573
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: Hauge ll Airway Conscious Sedation Kit with 7' Co2/O2 line with , male luer connectors, headstrap, tongue depressor, 2" pigtail with female luer

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:	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?
42420	Oesophageal-obturating/tracheal airway, single-use	A two-lumen, semiflexible, single-use tube inserted blindly through the mouth into the oesophagus or trachea to maintain airway patency while obturating the oesophagus, typically during emergencies to facilitate breathing/resuscitation. The oesophageal-obturating lumen has a blocked distal end and perforations at the pharyngeal level. A large oropharyngeal balloon seals mouth and nose; a distal cuff seals either the oesophagus or the trachea. Ventilation starts via the oesophageal tube, if the tube is in the oesophagus air enters the pharynx via the perforations; when the tube is in the trachea the ventilation is performed directly through the tracheal tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	Airway, Oropharyngeal, Anesthesiology

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: c40f8b97-7842-4ed8-863d-641eeaec57e6
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020