Ahead 300 International Charging Kit

FDA UDI

Class II (US FDA UDI)

by Brainscope

Identity

Trade Name: Ahead 300 International Charging Kit FDA UDI
Generic Name: Noninvasive device battery charger FDA UDI
Model / Reference: 99-1403-028 FDA UDI

Identifiers

Primary DI / UDI-DI: 00852745007017 FDA UDI
510(k) Number: K161068 FDA UDI
FDA Product Code: OLU FDA UDI
PKQ FDA UDI
PIW FDA UDI
GMDN Term: Noninvasive device battery charger FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1470 FDA UDI
882.1450 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Noninvasive device battery charger

Ahead 300 International Charging Kit by Brainscope — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Noninvasive device battery charger.

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Cleared under the same submission

K161068 also covers:

Ahead 300 — BRAINSCOPE
Ahead Electrode Headset — BRAINSCOPE
Baseline Headset — BRAINSCOPE
BrainScope One International Charging Kit — BRAINSCOPE
Electrode Headset — BRAINSCOPE

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: Brainscope

Sources (1)

FDA UDI e45716ee-84ac-441d-b103-b2bfbaf223e6 34 fields · synced May 30, 2026