Device
A flexible tube, typically lubricated with a water-soluble gel, that is inserted through a naris to deliver supplemental oxygen (O2) to the nasopharynx. This is a single-use device...
Manufacturer
ASSOMEDIKA, OOO
ASSOMEDIKA, OOO
Model: 1103 200 012
DI: 04816415501126
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-19
Current Version: 2026-05-27
Description
A flexible tube, typically lubricated with a water-soluble gel, that is inserted through a naris to deliver supplemental oxygen (O2) to the nasopharynx. This is a single-use device.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9e0ffdb3-1656-449c-9b5e-1fb3eb65f626
Distribution Status:
In Commercial Distribution
DUNS Number:
683522555
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
Device ID:
04816415501126
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35203
Name: Oxygen administration nasal catheter
Definition:
A flexible tube, typically lubricated with a water-soluble gel, that is inserted through a naris to deliver supplemental oxygen (O2) to the nasopharynx. This is a single-use device.
FDA Product Codes
BZB
Catheter, Nasal, Oxygen