Identity
- Trade Name
- JUMAX FDA UDI
- Generic Name
- Physiologic-monitoring defibrillation system FDA UDI
- Device Name
- Upper Arm Electronic Blood Pressure Monitor FDA UDI
- Model / Reference
- A27 FDA UDI
- Description
- Upper Arm Electronic Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002217208 FDA UDI
- 510(k) Number
- K131558 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Physiologic-monitoring defibrillation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
FDA UDI
Category: Physiologic-monitoring defibrillation system
Jumax by Jumax Healthcare Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physiologic-monitoring defibrillation system.
- LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
- LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
- R SERIES — Zoll Medical Corporation · Class II
- LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
- X SERIES — Zoll Medical Corporation · Class II
- LIFEPAK 35 Monitor/Defibrillator — PHYSIO-CONTROL, Inc. · Class III
- LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
- X SERIES — Zoll Medical Corporation · Class II
Cleared under the same submission
K131558 also covers:
- Sensiv — Acutens Inc
- BodyMed — BOXOUT, LLC
- BodyMed — BOXOUT, LLC
- Flexmed — RBD GROUP, LLC
- ANKOVO — Shenzhen Lingku Ecommerce Co., Ltd.
- FANRY — Shenzhen Lingku Ecommerce Co., Ltd.
- Metene — Shenzhen Lingku Ecommerce Co., Ltd.
- Metene — Shenzhen Lingku Ecommerce Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic 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 |
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Manufacturer
- Manufacturer
- Jumax Healthcare Llc
Sources (1)
- FDA UDI 1961b280-a326-470e-93fe-e9bc2816ead5 35 fields · synced Jun 1, 2026