Identity
- Trade Name
- Disposable Cuff FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Model / Reference
- 98-0400-13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840935103011 FDA UDI
- 510(k) Number
- K080854 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Blood pressure cuff, reusable 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Blood pressure cuff, reusable
Our Disposable Cuff is a clinically validated, inelastic sleeve-based blood pressure cuff designed for accurate and reliable blood pressure measurement. The disposable cuff features an inflatable bladder wrapped around the upper arm or leg of the patient, allowing for precise pressure readings throughout the entire range of systolic to diastolic pressures. Made from medical-grade materials, this reusable device is suitable for single-patient or multi-patient use, and can be used in a variety of clinical settings.
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Sklar® — Sklar Corporation · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K080854 also covers:
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
- Disposable Cuff — SUNTECH MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Suntech Medical, Inc.
Sources (1)
- FDA UDI 6c6c211f-fc4b-4d73-a8a0-84846af7db21 34 fields · synced Jul 25, 2026