FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelAir
DI: 00842071131890
·
Model: EIA-20-2612
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IntelAir
- Primary DI
- 00842071131890
- Version / Model
- EIA-20-2612
- Catalog Number
- EIA-20-2612, IA-20-2612-05
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-24
- Public Version
- 2
- Public Version Date
- 2025-04-07
- Public Version Status
- Update
- Public Device Record Key
- c8a75dcc-c72f-4371-97a2-f8f1ab8d4a86
Device Description
IntelAir, Tape Secured, without O2/CO2 Tubes, 26F x 12 cm (Pouch)
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
- MR Safe
- 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 | 00842071131975 | GS1 | Box (IA-20-2612-05) | 5 | In Commercial Distribution | |
| Primary | 00842071131890 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142467 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Centimeter |