Identity
- Trade Name
- Ultrasonic Pocket Doppler FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Model / Reference
- SD3 Vascular FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413802032 FDA UDI
- 510(k) Number
- K140579 FDA UDI
- FDA Product Code
- KNG FDA UDIDPW FDA UDI
- GMDN Term
- Foetal Doppler system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2660 FDA UDI870.2100 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
Category: Foetal Doppler system
Ultrasonic Pocket Doppler by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal Doppler system.
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Hi-dop — Bistos Co., Ltd. · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- VCOMIN Fetal Doppler — Vcomin Technlogy Limited · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- DigiDop — Newman Medical · Class II
- MediChoice — CooperSurgical, Inc. · Class II
Cleared under the same submission
K140579 also covers:
- Ultrasonic Pocket Doppler — Edan Instruments, Inc.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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
- Edan Instruments, Inc.
Sources (1)
- FDA UDI 2e006188-37f7-4dd0-a7c5-eacb65cef854 33 fields · synced Jun 8, 2026