Identity
- Trade Name
- Reusable Blood Pressure Cuff EUDAMEDVistarmed FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Reusable Blood Pressure Cuff EUDAMEDReusable Bladderless NIBP cuff,Adult,single tube, Slip luer connector FDA UDI
- Model / Reference
- V0014C-ML EUDAMEDFDA UDI
- Description
- Reusable Bladderless NIBP cuff,Adult,single tube, Slip luer connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521876447 EUDAMEDFDA UDI
- Basic UDI-DI
- 697352187RBPCPK EUDAMED
- 510(k) Number
- K152468 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vistarmed by Shenzhen Vistar Medical Supplies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K152468 also covers:
- FORA — FORA CARE INC.
- VASOCUFF — Newman Medical
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies Co., Ltd.
- Vistarmed — Shenzhen Vistar Medical Supplies 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 Vistar Medical Supplies Co., Ltd.
Sources (2)
- FDA UDI 5ca5b544-ef18-42b3-a2bf-e077c976798c 34 fields · synced Oct 7, 2026
- EUDAMED fa7fdfac-d983-4b90-aedc-a665fd443bc1 61 fields · synced Jul 9, 2026