Identity
- Trade Name
- AIV FDA UDI
- Generic Name
- Tocodynamometer probe FDA UDI
- Device Name
- Fetal Transducer Coro Toco Belt FDA UDI
- Model / Reference
- FM10839 FDA UDI
- Description
- Fetal Transducer Coro Toco Belt FDA UDI
Identifiers
- Catalog Number
- FM10839 FDA UDI
- Primary DI / UDI-DI
- M745FM10839 FDA UDI
- 510(k) Number
- K040392 FDA UDI
- FDA Product Code
- HFM FDA UDI
- GMDN Term
- Tocodynamometer probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2720 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 122.75 Inch FDA UDIHeight — 0.8 Inch FDA UDIOuter Diameter — 2.75 Inch FDA UDI
Category: Tocodynamometer probe
Aiv by American I.v. Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tocodynamometer probe.
- Cetro America Toco Transducer for all Coro models, Waterproof — Cetro America · Class II
- Cetro America Toco Transducer for all Coro models — Cetro America · Class II
- TOCO Transducer — Edan Instruments, Inc. · Class II
- FEATHERLITE TOCO — Parker Hannifin Corp. · Class II
- Cetro America Toco Transducer for HP 1350+, Waterproof — Cetro America · Class II
- Avalon TOCO MP Transducer — Philips Medizin Systeme Böblingen GmbH · Class II
- FEATHERLITE AQUA — Parker Hannifin Corp. · Class II
- FEATHERLITE TOCO — Parker Hannifin Corp. · Class II
Cleared under the same submission
K040392 also covers:
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
- American I.v. Products, Inc.
Sources (1)
- FDA UDI 31d5a5ef-1e07-4626-a785-9dba61ca5f03 37 fields · synced May 31, 2026