FDA UDI
In Commercial Distribution
🇺🇸 United States
Model EMV+, Comm, MRI
DI: 00847946020767
·
Model: 799-EMVP-05
·
Zoll Medical Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Model EMV+, Comm, MRI
- Primary DI
- 00847946020767
- Version / Model
- 799-EMVP-05
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-01
- Public Version
- 1
- Public Version Date
- 2022-11-09
- Public Version Status
- New
- Public Device Record Key
- 0d29aac5-a75e-4535-a02d-21d4f253fa09
Device Description
MAIN ASSY,EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPPLY, 6' OXYGEN HOSE, 12VDC CABLE, MRI, VENTILATOR CIRCUITS, SPO2 CABLE, SPO2 SENSOR, PADDED CASE, COMMERCIAL US
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| CBK | Ventilator, continuous, facility use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36289 | Transport electric ventilator | An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946020767 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius