Identity
- Trade Name
- tremoflo C2 Device - Yellow - VTG 28554 FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- The tremoflo C2 Device - Yellow - VTG 28554 is the device associated with the tremoflo C2 Airwave Oscillometry System and Accessories. This tremoflo C2 device is intended for use with Vitalograph 28554 filters. This device is part of the tremoflo C2 Airwave Oscillometry System. Refer to UDI 07540261020360 (Packaging DI) for more details. FDA UDI
- Model / Reference
- 102237 FDA UDI
- Description
- The tremoflo C2 Device - Yellow - VTG 28554 is the device associated with the tremoflo C2 Airwave Oscillometry System and Accessories. This tremoflo C2 device is intended for use with Vitalograph 28554 filters. This device is part of the tremoflo C2 Airwave Oscillometry System. Refer to UDI 07540261020360 (Packaging DI) for more details. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261022371 FDA UDI
- FDA Product Code
- PNV FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Pulmonary function analysis system, adult
tremoflo C2 Device - Yellow - VTG 28554 by Thorasys Thoracic Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thorasys Thoracic Medical Systems Inc
Sources (1)
- FDA UDI e90c37b9-859a-4028-915f-e15fd0cddc80 34 fields · synced Jun 6, 2026