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, NEONATAL3, 2 TB MALE SLIP, 06 - 11 CM, SINGLE FDA UDI
Model / Reference: 2523 FDA UDI
Description: SOFT-CUF, NEONATAL3, 2 TB MALE SLIP, 06 - 11 CM, SINGLE FDA UDI

Identifiers

Catalog Number: 2523 FDA UDI
Primary DI / UDI-DI: 00840682106269 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood pressure cuff, reusable

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

Similar devices

Also classified as Blood pressure cuff, reusable.

Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
Orbit-K — SUNTECH MEDICAL, INC. · Class II
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

K120125 also covers:

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: Ge Medical Systems Information Technologies, Inc.

Sources (1)

FDA UDI 7e491798-5d01-4a41-a864-ce07e9ba8c0f 38 fields · synced Jun 8, 2026