Identity
- Trade Name
- Tech-Med FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Black Nylon cuff , 2Tb ,Latex Free, Adult FDA UDI
- Model / Reference
- 2972LF-2A FDA UDI
- Description
- Black Nylon cuff , 2Tb ,Latex Free, Adult FDA UDI
Identifiers
- Catalog Number
- 2972LF-2A FDA UDI
- Primary DI / UDI-DI
- 00665973016825 FDA UDI
- 510(k) Number
- K082542 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
- Not 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
Tech-Med by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K082542 also covers:
- ASA Techmed — CARDICARE COMPANY LTD
- Leader — Cardinal Health 110, Inc.
- HealthSmart — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
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 ed2ea4ac-fa3f-4692-bae2-67d5d215088a 37 fields · synced May 30, 2026