Identity
- Trade Name
- ThermoFlo® FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- CircuitGuard ThermoFlo 1 Filter - Combined HME, Bacterial Viral Filter w O2 Port (Kung Shin) FDA UDI
- Model / Reference
- 6001 FDA UDI
- Description
- CircuitGuard ThermoFlo 1 Filter - Combined HME, Bacterial Viral Filter w O2 Port (Kung Shin) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810050855662 FDA UDI
- 510(k) Number
- K032878 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Heat/moisture exchanger/microbial medical gas filter
ThermoFlo® by Typenex Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heat/moisture exchanger/microbial medical gas filter.
- Ulti-MistHME/F Angled — KING SYSTEMS CORPORATION. · Class II
- AirLife™ — Airlife, Inc. · Class I
- DAR — Covidien LP · Class I
- Disposable Anesthesia Circuit — WESTMED, INC. · Class I
- ThermoShield Adult Bacterial Viral HMEF — FLEXICARE MEDICAL LIMITED · Class II
- Hygrovent Gold Comfort — FLEXICARE MEDICAL LIMITED · Class II
- Hsiner — Hsiner Company · Class II
- LuerSafe Adult Bacterial Viral HMEF with Self-Sealing Luer Port — FLEXICARE MEDICAL LIMITED · Class II
Cleared under the same submission
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
- Typenex Medical, LLC
Sources (1)
- FDA UDI 0b5c01a7-9935-4569-8c68-7252801d7867 35 fields · synced May 30, 2026