Identity
- Trade Name
- Pulse Oximeter EUDAMEDpluse oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- JPD-500B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06951740538350 EUDAMED06951740500180 FDA UDI
- Basic UDI-DI
- 69517405SP01TL EUDAMED
- Direct Marketing DI
- 06951740538350 EUDAMED
- 510(k) Number
- K140582 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
pluse oximeter by Shenzhen Jumper Medical Equipment Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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.
- Alcedo — Nature Major 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
- Shenzhen Jumper Medical Equipment Co., Ltd.
Sources (2)
- FDA UDI da5e5350-8f9b-4d5d-9b4d-53a4b81783bf 33 fields · synced Oct 6, 2026
- EUDAMED b24333e9-5b5b-49f8-af88-7b0ccd222983 61 fields · synced Jul 16, 2026