Device
NDAM211
Manufacturer
ENDURE INDUSTRIES
Model: NDAM211 Catalog: NDAM211 DI: 00840118613958 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-01 Current Version: 2026-05-11
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f04beb67-96e8-43db-85b4-dfdca8184155
Distribution Status: In Commercial Distribution
DUNS Number: 066087031
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Pack of 5
Item #1 - Device ID: 00840118620369
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 5
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00840118613958
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00840118613958
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Case of 40
Item #3 - Device ID: 00840118613965
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 40
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 00840118613958
Item #3 - Device ID Issuing Agency: GS1
Item #4 - Pkg Type: Case of 160
Item #4 - Device ID: 00840118622608
Item #4 - Pkg Status: In Commercial Distribution
Item #4 - Pkg Quantity: 160
Item #4 - Device ID Type: Package
Item #4 - Contains DINumber: 00840118613958
Item #4 - Device ID Issuing Agency: GS1
GMDN
Code: 36306
Name: Nasal oxygen cannula, carbon-dioxide-sampling
Definition:
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.
FDA Product Codes
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 0
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 49
Storage Handling - Storage Handling Type: Handling Environment Temperature