Identity
- Trade Name
- Areta Fingertip Pulse Oximeter FDA UDI
- Generic Name
- Telemetric pulse oximeter FDA UDI
- Model / Reference
- EZD-500A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850253007109 FDA UDI
- 510(k) Number
- K140582 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Telemetric 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
Yes
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: Telemetric pulse oximeter
Areta Fingertip Pulse Oximeter by Easy Healthcare Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Telemetric pulse oximeter.
- AMC — Advantage Medical Electronics, LLC · Class II
- VIVE — VIVE HEALTH LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- Tenovi — TENOVI CO · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · 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.
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Easy Healthcare Corporation
Sources (1)
- FDA UDI 87518235-cf96-4483-89de-1125893c95b1 33 fields · synced Jun 8, 2026