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Tech-Med

FDA UDI

Class II (US FDA UDI)

by Dukal LLC

Identity

Trade Name
Tech-Med FDA UDI
Generic Name
Blood pressure cuff, reusable FDA UDI
Device Name
Standard Sphyg., Nylon Black, Lg. Adult Latex Free FDA UDI
Model / Reference
2030X FDA UDI
Description
Standard Sphyg., Nylon Black, Lg. Adult Latex Free FDA UDI

Identifiers

Catalog Number
2030X FDA UDI
Primary DI / UDI-DI
00665973017051 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

Dimensions & Sizes

Size
Weight — 0.52 Kilogram 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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dukal LLC

Sources (1)

  • FDA UDI 5ea549e9-2d65-40c6-820a-9a65d0f49e1f 38 fields · synced Jun 1, 2026