Identity
- Trade Name
- BV Medical FDA UDI
- Generic Name
- Oxygen saturation/pulse rate electronic-signal simulator FDA UDI
- Device Name
- Finger Pulse Oximeter, Adult Model, PI, Black with Green Display FDA UDI
- Model / Reference
- 50-200-010-L FDA UDI
- Description
- Finger Pulse Oximeter, Adult Model, PI, Black with Green Display FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845821031310 FDA UDI
- 510(k) Number
- K140582 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Oxygen saturation/pulse rate electronic-signal simulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxygen saturation/pulse rate electronic-signal simulator
BV Medical by Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen saturation/pulse rate electronic-signal simulator.
- VIVE — VIVE HEALTH LLC · Class II
- BV Medical — Medical, Inc. · Class II
- BV Medical — Medical, Inc. · Class II
Cleared under the same submission
K140582 also covers:
- 1BYONE — 1BYONEPRODUCTS INC.
- Pulse Oximeter — BETTER BASICS, INC.
- Pulse oximeter — BETTER BASICS, INC.
- Pulse oximeter — BETTER BASICS, INC.
- Areta Fingertip Pulse Oximeter — EASY HEALTHCARE CORPORATION
- EMAY — EMAY (HK) LIMITED
- Touch — LEXINGTON WELLNESS HOLDINGS INC.
- FaceLake — LORTE TECHNOLOGIES, INC
- MEDLINE — MEDLINE INDUSTRIES, INC.
- iProvèn — Masena Invest B.V.
- Alcedo — Nature Major Inc.
- Pylo Health — PREVOUNCE HEALTH, 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
- Medical, Inc.
Sources (1)
- FDA UDI 408c4329-6efc-4f29-976c-00132ca580d7 35 fields · synced Jun 8, 2026