Identity
- Trade Name
- VORTRAN Airway Pressure Monitor FDA UDI
- Generic Name
- Airway pressure/oxygen monitor FDA UDI
- Device Name
- The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via the connection kit to monitor the cycling conditions of resuscitators. It give clinicians patient ventilation parameters (PIP, PEEP, Respiration Rate, I:E ratio) and provides visual alarm display with flashing LED and loud audible alarm. It allows clinicians to have a true value of patient status during ventilation similar to a full-featured ventilator. It is easy to set up and use. Offers different connection kit options. FDA UDI
- Model / Reference
- APM-3900 FDA UDI
- Description
- The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via the connection kit to monitor the cycling conditions of resuscitators. It give clinicians patient ventilation parameters (PIP, PEEP, Respiration Rate, I:E ratio) and provides visual alarm display with flashing LED and loud audible alarm. It allows clinicians to have a true value of patient status during ventilation similar to a full-featured ventilator. It is easy to set up and use. Offers different connection kit options. FDA UDI
Identifiers
- Catalog Number
- APM-3900 FDA UDI
- Primary DI / UDI-DI
- 10637320039006 FDA UDI
- 510(k) Number
- K103639 FDA UDI
- FDA Product Code
- CAP FDA UDI
- GMDN Term
- Airway pressure/oxygen monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Airway pressure/oxygen monitor
VORTRAN Airway Pressure Monitor by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway pressure/oxygen monitor.
- Pneupac — ICU MEDICAL, INC. · Class II
- VAR-Monitor — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- VORTRAN® APM-Plus — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vortran Medical Technology 1, Inc.
Sources (1)
- FDA UDI dad08cd2-75a2-4e1c-b1d7-04b7d15ecb29 36 fields · synced May 31, 2026