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TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 100986
Identity
- Trade Name
- Calibrated Reference Load 2cmH2O.s/L EUDAMEDTremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Calibrated Reference Load 2cmH2O.s/L EUDAMEDReference load to verify TremoFlo Oscillometry System calibration. FDA UDI
- Model / Reference
- 100986 EUDAMEDFDA UDI
- Description
- Reference load to verify TremoFlo Oscillometry System calibration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261009860 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540261009860 EUDAMED
- 510(k) Number
- K170185 FDA UDI
- FDA Product Code
- PNV FDA UDI
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L by Thorasys Thoracic Medical Systems Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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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
- tF C-100 Unit-ClearFlo PFT filter compatible — Thorasys Thoracic Medical Systems Inc
- tF Calibrated Reference Load 15cmH2O (2 Years Edition) — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI c0ebf0c8-cca1-45cc-abad-9eeb7a13158b 35 fields · synced Jul 14, 2026
- EUDAMED 81f9cf67-ef5e-4065-a887-68419684a790 61 fields · synced Jul 14, 2026