FDA UDI In Commercial Distribution 🇺🇸 United States

ETCO2 Nasal Cannula

DI: 00850014433215 · Model: 1 · DISTRIBUTION UNLIMITED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ETCO2 Nasal Cannula
Primary DI
00850014433215
Version / Model
1
Catalog Number
DU1090
Company Name
DISTRIBUTION UNLIMITED, LLC
Labeler DUNS
926603486
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-13
Public Version
2
Public Version Date
2022-03-22
Public Version Status
Update
Public Device Record Key
a840809d-0ecc-41ac-9ba6-fcbf73d2a037

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

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CAT Cannula, Nasal, Oxygen

GMDN Terms

Code Name
36306 Nasal oxygen cannula, carbon-dioxide-sampling

Identifiers

Type ID
Package 20850014433219
Primary 00850014433215

Device Sizes

Type Value Unit Text
Length 7 Feet