FDA UDI
In Commercial Distribution
🇺🇸 United States
Intelair Nasal Airway Support System
DI: 00842071113650
·
Model: ENR212611
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Intelair Nasal Airway Support System
- Primary DI
- 00842071113650
- Version / Model
- ENR212611
- Catalog Number
- ENR212611, NR212611-1, NR212611-3
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-01
- Public Version
- 1
- Public Version Date
- 2023-07-10
- Public Version Status
- New
- Public Device Record Key
- 3baffb0f-4101-47ca-9954-c3c199318c9a
Device Description
Airway Assembly, 11cm, Pouched
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071113698 | GS1 | Box 1 (NR212611-1) | 1 | In Commercial Distribution | |
| Primary | 00842071113650 | GS1 | ||||
| Package | 00842071113704 | GS1 | Box 3 (NR212611-3) | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 11 | Centimeter |