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tremoflo C2 Airwave Oscillometry System and Accessories
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- tremoflo C2 Airwave Oscillometry System and Accessories FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- The tremoflo C2 Airwave Oscillometry System and Accessories features the following: a tremoflo C2 device (device model varies depending on the filter designated for use), a reference test load (model 101947), a USB power supply and changeable power supply blade (depending on the region of use), a user manual (depending on the region of use), and the tremoflo software license (depending on customer requirements). FDA UDI
- Model / Reference
- 102036 FDA UDI
- Description
- The tremoflo C2 Airwave Oscillometry System and Accessories features the following: a tremoflo C2 device (device model varies depending on the filter designated for use), a reference test load (model 101947), a USB power supply and changeable power supply blade (depending on the region of use), a user manual (depending on the region of use), and the tremoflo software license (depending on customer requirements). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261020360 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 Airwave Oscillometry System and Accessories by Thorasys Thoracic Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID
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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
- Thorasys Thoracic Medical Systems Inc
Sources (1)
- FDA UDI 94609dd5-7ee9-4018-8383-7e29d810192d 34 fields · synced May 31, 2026