Identity
- Trade Name
- Vistarmed FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- 1,Disposable for single patient use only,to avoid potential cross-infection. 2,Material:white color PVC coated non-woven fabrics 3,One-piece/bladderless design,neat and comfortable 4,Round corner design,with better appearance and patient's comfort 5,Compatible with most brands of patient monitors 6,Full range of 13 sizes to fit most patient's arm from neonate to thigh 7,Available with single tube and double tubes 8,Latex Free&biocompatibility tested 9,Compliance with ANSI/AAMI SP10-2002,EN60601-1:1990 FDA UDI
- Model / Reference
- Disposable blood pressure cuff FDA UDI
- Description
- 1,Disposable for single patient use only,to avoid potential cross-infection. 2,Material:white color PVC coated non-woven fabrics 3,One-piece/bladderless design,neat and comfortable 4,Round corner design,with better appearance and patient's comfort 5,Compatible with most brands of patient monitors 6,Full range of 13 sizes to fit most patient's arm from neonate to thigh 7,Available with single tube and double tubes 8,Latex Free&biocompatibility tested 9,Compliance with ANSI/AAMI SP10-2002,EN60601-1:1990 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521870018 FDA UDI
- 510(k) Number
- K152465 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Blood pressure cuff, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Blood pressure cuff, single-use
Vistarmed by Shenzhen Vistar Medical Supplies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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 (1)
- FDA UDI 73456dcd-ddf7-40a7-a550-f975e496a0f1 34 fields · synced May 30, 2026