Fukuda Denshi

FDA UDI

Class II (US FDA UDI)

by Fukuda Denshi Co., Ltd.

Identity

Trade Name: FUKUDA DENSHI FDA UDI
Generic Name: External cuff/pad connection tubing FDA UDI
Model / Reference: OA-80NE3.5 FDA UDI

Identifiers

Primary DI / UDI-DI: 04538612909702 FDA UDI
510(k) Number: K150030 FDA UDI
FDA Product Code: MHX FDA UDI
GMDN Term: External cuff/pad connection tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1025 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

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

FDA UDI

Category: External cuff/pad connection tubing

Fukuda Denshi by Fukuda Denshi Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External cuff/pad connection tubing.

MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
Orantech — Orantech Inc. · Class I
Orantech — Orantech Inc. · Class I
Orantech — Orantech Inc. · Class I
Orantech — Orantech Inc. · Class I
ThermaZone — INNOVATIVE MEDICAL EQUIPMENT · Class II
Orantech — Orantech Inc. · Class I
Orantech — Orantech Inc. · Class I

Cleared under the same submission

K150030 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fukuda Denshi Co., Ltd.

Sources (1)

FDA UDI 9f978a8b-5900-4d28-b135-a5ed36170b18 33 fields · synced Jun 6, 2026