FDA UDI
In Commercial Distribution
🇺🇸 United States
Emergent Respiratory
DI: 00850071887242
·
Model: 1900-001
·
MDL Solutions Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Emergent Respiratory
- Primary DI
- 00850071887242
- Version / Model
- 1900-001
- Company Name
- MDL Solutions Incorporated
- Labeler DUNS
- 117921082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-05
- Public Version
- 1
- Public Version Date
- 2025-04-14
- Public Version Status
- New
- Public Device Record Key
- 37809bd7-abcb-4f28-9c3d-a0594e0e6e9d
Device Description
PortO2 Vent CPAP
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41148 | Portable pneumatic ventilator | A pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850071887242 | GS1 |
Customer Contacts
- Phone
- 6125427979
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021520 | 000 |