AccessGUDID - DEVICE: Shiley (40884521105554)

GUDID

Device Identifier (DI) Information

Brand Name: Shiley
Version or Model: 5-18537
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 40884521105554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Esophageal Tracheal Airway with X-Ray Line,Double Lumen. Manufactured under license of Frass and Frenzer.

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):	Yes
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?
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
CAO	AIRWAY, ESOPHAGEAL (OBTURATOR)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K875226	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 32 and 90 Degrees Fahrenheit
Special Storage Condition, Specify: No UV

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 37 French

Device Record Status

Public Device Record Key: 1c629ec3-95e4-4226-ae3d-17f235d5c1a6
Public Version Date: June 24, 2025
Public Version Number: 9
DI Record Publish Date: March 22, 2017