Identity
- Trade Name
- NeoPad "T" AC to DC Power Supply Cable FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Model / Reference
- 9401 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078001925 FDA UDI
- 510(k) Number
- K870173 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use 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
Yes
FDA UDI
NeoPad "T" AC to DC Power Supply Cable 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 e5bdafd9-aaa6-4ad3-b723-fec6ca2a46b6 34 fields · synced May 30, 2026