AccessGUDID - DEVICE: Nasopharyngeal Airway 30FR (M689HHNPA30CA0105)

GUDID

Device Identifier (DI) Information

Brand Name: Nasopharyngeal Airway 30FR
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HHNPA30-CA
Company Name: Safeguard US Operating, LLC

Primary DI Number: M689HHNPA30CA0105
Issuing Agency: HIBCC
Commercial Distribution End Date: June 02, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: HHNPA30-NS-EA H&H Nasopharyngeal L01-0022 x 4 white, blank label P31-207Zip Bag, 12x12 f/ CR

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
45036	Laryngeal mask airway, single-use	A curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 1db5d0c2-a0c1-402f-8661-89e91a2a1eee
Public Version Date: June 15, 2022
Public Version Number: 1
DI Record Publish Date: June 07, 2022