Identity
- Trade Name
- PURE ENRICHMENT FDA UDI
- Generic Name
- Foetal Doppler system FDA UDI
- Device Name
- Fetal Doppler. Used to hear heart rate sounds. FDA UDI
- Model / Reference
- PEFETDPL FDA UDI
- Description
- Fetal Doppler. Used to hear heart rate sounds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B311PEFETDPL0 FDA UDI
- 510(k) Number
- K131457 FDA UDI
- FDA Product Code
- KNG FDA UDI
- GMDN Term
- Foetal Doppler system 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foetal Doppler system
Pure Enrichment by Bear Down Consulting — 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
K131457 also covers:
- Baby Doppler — DAGAMMA INC.
- Sweetiesong Fetal Doppler — EASY HEALTHCARE CORPORATION
- Sweetiesong Fetal Doppler — EASY HEALTHCARE CORPORATION
- Little Martin's Drawer — EBZNS HOLDINGS LLC
- Gynex — GYNEX CORPORATION
- FaceLake — LORTE TECHNOLOGIES, INC
- HYLOGY — Shenzhen Jumper Medical Equipment Co., Ltd.
- Jumper — Shenzhen Jumper Medical Equipment Co., Ltd.
- Jumper — Shenzhen Jumper Medical Equipment Co., Ltd.
- fetal doppler — Shenzhen Jumper Medical Equipment Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bear Down Consulting
Sources (1)
- FDA UDI a341b9c0-2744-4ac2-a8ad-644ead929b26 34 fields · synced Jun 7, 2026