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tF Calibrated Reference Load 15cmH2O (2 Years Edition)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- tF Calibrated Reference Load 15cmH2O (2 Years Edition) FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- 2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration. FDA UDI
- Model / Reference
- 102069 FDA UDI
- Description
- 2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261020698 FDA UDI
- 510(k) Number
- K170185 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
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: Pulmonary function analysis system, adult
tF Calibrated Reference Load 15cmH2O (2 Years Edition) by Thorasys Thoracic Medical Systems Inc — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K170185 also covers:
- Assembly of tremoflo US software and digital user manual CD — Thorasys Thoracic Medical Systems Inc
- TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L — Thorasys Thoracic Medical Systems Inc
- TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L — Thorasys Thoracic Medical Systems Inc
- tF C-100 Unit-ClearFlo PFT filter compatible — Thorasys Thoracic Medical Systems Inc
- tf C-100 Kit Vitalograph - Clinical Trial Edition (28300) — Thorasys Thoracic Medical Systems Inc
- tf C-100 Kit Vitalograph - Healthcare Edition (28500) — Thorasys Thoracic Medical Systems Inc
- tremoFlo US Software — Thorasys Thoracic Medical Systems Inc
- tremoflo C-100 Airwave Oscillometry - Support Arm — Thorasys Thoracic Medical Systems Inc
- tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition — Thorasys Thoracic Medical Systems Inc
- tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition — Thorasys Thoracic Medical Systems Inc
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 4d6f9699-1617-4199-8efa-8d8e0877fb75 35 fields · synced May 30, 2026