FDA UDI
In Commercial Distribution
🇺🇸 United States
NomoLine-O LH Pediatric Nasal CO2 Cannula with O2
DI: 17350046132228
·
Model: 4457
·
Masimo Sweden AB
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- NomoLine-O LH Pediatric Nasal CO2 Cannula with O2
- Primary DI
- 17350046132228
- Version / Model
- 4457
- Company Name
- Masimo Sweden AB
- Labeler DUNS
- 632369067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-06-27
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 5ffe1fb2-fe08-4ba5-810e-a112a183baae
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 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
| BYH | Drain, Tee (Water Trap) | Anesthesiology | 868.5995 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45566 | Gas-sampling/monitoring respiratory tubing, single-use | A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17350046132228 | GS1 | ||||
| Unit of Use | 07350046132221 | GS1 |