MediMax Tech

FDA UDI

Class II (US FDA UDI)

by Medimax Tech Inc.

Identity

Trade Name: MediMax Tech FDA UDI
Generic Name: Neonatal electrocardiographic electrode FDA UDI
Device Name: MXNSR15L: Neonatal ECG Electrodes, 22x36mm Size, Radiolucent, 3pcs/pack, 300pcs/box, 3,000pcs/Master Case FDA UDI
Model / Reference: MXNSR15L Neonatal Electrodes FDA UDI
Description: MXNSR15L: Neonatal ECG Electrodes, 22x36mm Size, Radiolucent, 3pcs/pack, 300pcs/box, 3,000pcs/Master Case FDA UDI

Identifiers

Primary DI / UDI-DI: 00817325021630 FDA UDI
510(k) Number: K053011 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Neonatal electrocardiographic electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neonatal electrocardiographic electrode

MediMax Tech by Medimax Tech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neonatal electrocardiographic electrode.

GE Healthcare — Leonhard Lang Co. · Class II
BlueSensor BRECG Electrodes — Ambu A/S · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
NeoLead® — Neotech Products LLC · Class II
BlueSensor BRSECG Electrodes — Ambu A/S · Class II
BlueSensor NEOXECG Electrodes — Ambu A/S · Class II
Kendall — Cardinal Health 200, LLC · Class II
Kendall — Cardinalhealth · Class II

Cleared under the same submission

K053011 also covers:

Vyaire — Airlife, Inc.
Vyaire — Airlife, Inc.
CareFusion — BIOPROTECH INC.
CareFusion — BIOPROTECH INC.
CARDINAL HEALTH — Cardinal Health 200, LLC
MediMax Tech — MEDIMAX TECH INC.
MediMax Tech — MEDIMAX TECH INC.
MediMax Tech — MEDIMAX TECH INC.
Medline — MEDLINE INDUSTRIES, INC.

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: Medimax Tech Inc.

Sources (1)

FDA UDI 742c8fb2-477d-4ef1-bd97-0447dacc3e05 35 fields · synced May 30, 2026