Identity
- Trade Name
- Anapod FDA UDI
- Generic Name
- Airway temperature monitoring system FDA UDI
- Device Name
- Refurbished Controller, Anapod Domestic w Mounting Bracket FDA UDI
- Model / Reference
- A2003-1R FDA UDI
- Description
- Refurbished Controller, Anapod Domestic w Mounting Bracket FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078007071 FDA UDI
- 510(k) Number
- K904538 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Anapod by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI 13db81cf-632c-48b7-be5d-e87dd1bdefda 35 fields · synced Jun 8, 2026