Identity
- Trade Name
- Clinical Guard FDA UDI
- Generic Name
- Foetal Doppler system probe FDA UDI
- Model / Reference
- Sonoline B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00897429002513 FDA UDI
- 510(k) Number
- K082480 FDA UDI
- FDA Product Code
- KNG FDA UDI
- GMDN Term
- Foetal Doppler system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2660 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
Yes
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
Category: Foetal Doppler systemFoetal Doppler system probe
Clinical Guard by Clinical Guard — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082480 also covers:
- CONTEC — Contec Medical Systems Co., Ltd.
- CONTEC — Contec Medical Systems Co., Ltd.
- CONTEC — Contec Medical Systems Co., Ltd.
- CONTEC — Contec Medical Systems Co., Ltd.
- Baby Doppler — DAGAMMA INC.
- Baby Doppler — DAGAMMA INC.
- FaceLake — LORTE TECHNOLOGIES, INC
- FaceLake — LORTE TECHNOLOGIES, INC
- FaceLake — LORTE TECHNOLOGIES, INC
- FaceLake — LORTE TECHNOLOGIES, INC
- FaceLake — LORTE TECHNOLOGIES, INC
- Neeva Baby — Sebe 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
- Clinical Guard
Sources (1)
- FDA UDI d4b5af30-5fc9-4c32-b1e6-5313549f6f96 33 fields · synced May 31, 2026