Trilogy O2 Ventilator, Japan - BT
- Primary DI
- 00606959052369
- Company
- Respironics, Inc.
- Model
- 00
- Catalog number
- 1040004B
- Published
- 2018-10-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Regulatory Flags
- DUNS number
- 080728314
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00606959052369 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 00606959052369 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| DQA | Oximeter | 2 | Cardiovascular | 870.2700 | N | Eligible |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K093905 | 000 |
Premarket Details
GMDN Terms
| Term | Definition |
|---|---|
| Portable electric ventilator | A portable, electrically-powered device intended to provide long-term alveolar 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 invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory). |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Humidity | 15 Percent (%) Relative Humidity | 95 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 60 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(724)744-2500 | RESPIRONICS.SERVICE@PHILIPS.COM |
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| 00606959425392 | DreamStation | 01 | CNX1131S17 | 2019-12-29 |
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| 00606959425569 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CA | CAX1130H12W | 2017-02-10 |
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