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Soft-Cuf

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems Information Technologies, Inc.

Identity

Trade Name
SOFT-CUF FDA UDI
Generic Name
Blood pressure cuff, reusable FDA UDI
Device Name
SOFT-CUF, LARGE ADULT LONG, 2 TB SUBMIN, 31 - 40 CM, SINGLE FDA UDI
Model / Reference
2117 FDA UDI
Description
SOFT-CUF, LARGE ADULT LONG, 2 TB SUBMIN, 31 - 40 CM, SINGLE FDA UDI

Identifiers

Primary DI / UDI-DI
00840682106641 FDA UDI
510(k) Number
K120125 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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

Yes

FDA UDI

Soft-Cuf by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K120125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ge Medical Systems Information Technologies, Inc.

Sources (1)

  • FDA UDI 9137cb53-750b-4736-bf14-50fa8be045b0 38 fields · synced Jun 8, 2026