Kenaflexx

FDA UDI

Class II (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name: KENAFLEXX FDA UDI
Generic Name: Blood pressure cuff, reusable FDA UDI
Device Name: NON INVASIVE BLOOD PRESSURE NYLON CUFF NEONATE #1 SINGLE USE FDA UDI
Model / Reference: 177701S FDA UDI
Description: NON INVASIVE BLOOD PRESSURE NYLON CUFF NEONATE #1 SINGLE USE FDA UDI

Identifiers

Catalog Number: 177701S FDA UDI
Primary DI / UDI-DI: 00851785007834 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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Blood pressure cuff, reusable

Kenaflexx by Kentron Health Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Blood pressure cuff, reusable.

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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

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: Kentron Health Care, Inc.

Sources (1)

FDA UDI 6d163b72-4e24-4718-a76a-3d5f8ddf82e9 35 fields · synced Jun 1, 2026