Vistarmed
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Disposable Blood Pressure Cuff EUDAMEDVistarmed FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- Disposable Blood Pressure Cuff EUDAMEDDisposable NIBP cuff,Neonate 5,double tube, no connector FDA UDI
- Model / Reference
- V1025N EUDAMEDFDA UDIphilips IntelliVue and Avalon, Drage Vista 120, GE CARESCAPE™ B850 , etc EUDAMED
- Description
- Disposable NIBP cuff,Neonate 5,double tube, no connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521876089 EUDAMEDFDA UDI
- Basic UDI-DI
- 697352187DBPCLH EUDAMED
- 510(k) Number
- K152465 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, single-use 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Blood pressure cuff, single-use
Vistarmed by Shenzhen Vistar Medical Supplies Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff, single-use.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orantech — Orantech Inc. · Class II
- Statcorp Medical — STATCORP MEDICAL · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Softcheck — STATCORP MEDICAL · Class II
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class II
- MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K152465 also covers:
- VASOCUFF — Newman Medical
- 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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Shenzhen Vistar Medical Supplies Co., Ltd.
Sources (2)
- FDA UDI 594ead82-8dbb-42e8-adb2-8912677ce6e2 34 fields · synced Oct 6, 2026
- EUDAMED 2fe0b79c-4ac1-4c0b-9874-4c3e82291ae4 61 fields · synced Oct 6, 2026