AccessGUDID - DEVICE: Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, Size 4.0 mm (00840117315594)

GUDID

Device Identifier (DI) Information

Brand Name: Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, Size 4.0 mm
Version or Model: 36298
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117315594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: Sterile-Eo

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?
47803	Reinforced laryngeal mask airway, single-use	A curved armoured 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 is wire reinforced to prevent kinking during patient movement. It may include a 15 mm connector, 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
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: 5eefbe75-84f0-4f29-83e6-1fc7e790eb5a
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: May 23, 2022