Identity
- Trade Name
- Alcedo FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Fingertip Pulse Oximeter FDA UDI
- Model / Reference
- AE174 FDA UDI
- Description
- Fingertip Pulse Oximeter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856471007204 FDA UDI
- 510(k) Number
- K140582 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter
Alcedo by Nature Major Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- BV Medical — Medical, 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
- Nature Major Inc.
Sources (1)
- FDA UDI 93811b5a-b92c-4052-9c23-88e4bd25fa8f 34 fields · synced May 30, 2026