Identity
- Trade Name
- Tech-Med FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Standard Sphyg., Nylon Black w/D-ring, Adult Latex Free,stethosope attached FDA UDI
- Model / Reference
- 2041 FDA UDI
- Description
- Standard Sphyg., Nylon Black w/D-ring, Adult Latex Free,stethosope attached FDA UDI
Identifiers
- Catalog Number
- 2041 FDA UDI
- Primary DI / UDI-DI
- 00665973016955 FDA UDI
- 510(k) Number
- K193259 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
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, reusable
Tech-Med by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood pressure cuff, reusable.
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- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K193259 also covers:
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- Tech-Med — Dukal LLC
- GAHAM FIELD — GF Health Products, Inc
- GRAHAM FIELD — GF Health Products, Inc
- GRAHAM FIELD — GF Health Products, Inc
- GRAHAM FIELD — GF Health Products, Inc
- Tempo — HEMASOURCE
- RITE AID — MICROLIFE USA, INC.
- HealthMart — STRATEGIC SOURCING SERVICES LLC
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
- Dukal LLC
Sources (1)
- FDA UDI 25d55306-e39d-442a-86cf-54a86dc73dcb 36 fields · synced Jun 1, 2026