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Self-Taking Blood Pressure Kit-Large Adult Size Cuff

FDA UDI

Class II (US FDA UDI)

by Omron Healthcare, Inc.

Identity

Trade Name
Self-Taking Blood Pressure Kit-Large Adult Size Cuff FDA UDI
Generic Name
Aneroid manual sphygmomanometer FDA UDI
Model / Reference
0104MAJ FDA UDI

Identifiers

Primary DI / UDI-DI
00073796010423 FDA UDI
510(k) Number
K780715 FDA UDI
FDA Product Code
DXQ FDA UDI
GMDN Term
Aneroid manual sphygmomanometer 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Aneroid manual sphygmomanometer

Self-Taking Blood Pressure Kit-Large Adult Size Cuff by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aneroid manual sphygmomanometer.

Cleared under the same submission

K780715 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omron Healthcare, Inc.

Sources (1)

  • FDA UDI 3b73bff0-3f4e-4820-badf-fe7b6bf93383 34 fields · synced May 30, 2026