Identity
- Trade Name
- Anapod Controller FDA UDI
- Generic Name
- Airway temperature monitoring system FDA UDI
- Device Name
- Anapod Controller FDA UDI
- Model / Reference
- A2003R FDA UDI
- Description
- Anapod Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078001161 FDA UDI
- 510(k) Number
- K870173 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Airway temperature monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Commercial Distribution
- Not 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
Anapod Controller by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K870173 also covers:
- NeoPod T, Neonatal Transport Humidification System — INTERNATIONAL BIOMEDICAL, LTD.
- Co-Flo Heated Humidified Circuit — WESTMED, INC.
- Controllers/Accessories — WESTMED, INC.
- NeoPad "T" Power Supply Cable — WESTMED, INC.
- NeoPod "T" AC to DC Power Supply Cable — WESTMED, INC.
- NeoPod T — WESTMED, INC.
- NeoPod `T` Transport Controller, W/Pole mounting bracket — WESTMED, INC.
- NeoPod `T` Transport Controller, W/Pole mounting bracket — WESTMED, 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
- Westmed, Inc.
Sources (1)
- FDA UDI 665f5666-a57e-4c50-860d-467b1032d16b 35 fields · synced Jun 1, 2026