Identity
- Trade Name
- CKeep FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Model / Reference
- PG-800A12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00739810204208 FDA UDI
- 510(k) Number
- K131569 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient monitoring system module, blood pressure, noninvasive
CKeep by Shenzhen Lingku Ecommerce Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient monitoring system module, blood pressure, noninvasive.
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- Rite365 — MAYBEAM LLC · Class II
- BOTHEALTH — Shenzhen BSX Technology Electronics Co., Ltd. · Class II
- Finapres — Finapres Medical Systems B.V. · Class II
- MedSource Blood Pressure Unit, Large Adult — MEDSOURCE INTERNATIONAL LLC · Class II
Cleared under the same submission
K131569 also covers:
- Sensiv — Acutens Inc
- MedOne — MEDONE LLC
- Electronic Blood Pressure Monitor — Shenzhen Jumper Medical Equipment 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.
- 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.
- 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
- Shenzhen Lingku Ecommerce Co., Ltd.
Sources (1)
- FDA UDI b5e866db-40f8-4834-83bb-3b7998abe962 33 fields · synced May 30, 2026