AccessGUDID - DEVICE: ETCO2 Nasal Cannula (00850014433215)

GUDID

Device Identifier (DI) Information

Brand Name: ETCO2 Nasal Cannula
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DU1090
Company Name: DISTRIBUTION UNLIMITED, LLC

Primary DI Number: 00850014433215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926603486 *Terms of Use

Device Description: A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs.

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):	No
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?
36306	Nasal oxygen cannula, carbon-dioxide-sampling	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	Cannula, Nasal, Oxygen

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
Length: 7 Feet

Device Record Status

Public Device Record Key: a840809d-0ecc-41ac-9ba6-fcbf73d2a037
Public Version Date: March 22, 2022
Public Version Number: 2
DI Record Publish Date: August 13, 2020