Identity
- Trade Name
- VAR-Monitor FDA UDI
- Generic Name
- Airway pressure/oxygen monitor FDA UDI
- Device Name
- The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient contact during its operation. If the VAR stops cycling, the VAR-Monitor™ detects the non-cycling condition and generates both an audible sound and a visible blinking (red color LED) light alerting the clinician who is attending the patient. FDA UDI
- Model / Reference
- VM-3500 FDA UDI
- Description
- The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient contact during its operation. If the VAR stops cycling, the VAR-Monitor™ detects the non-cycling condition and generates both an audible sound and a visible blinking (red color LED) light alerting the clinician who is attending the patient. FDA UDI
Identifiers
- Catalog Number
- VM-3500 FDA UDI
- Primary DI / UDI-DI
- 20637320035005 FDA UDI
- 510(k) Number
- K073261 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Airway pressure/oxygen monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 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
VAR-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
- VORTRAN Airway Pressure 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 c3210684-b3a7-4850-9814-090cce7d6a46 36 fields · synced May 30, 2026