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Rhythmlink®

FDA UDI

Class II (US FDA UDI)

by Rhythmlink International, LLC

Identity

Trade Name
Rhythmlink® FDA UDI
Generic Name
Electroencephalographic electrode cap, single-use FDA UDI
Device Name
2 electrode arrays, 7mm diameter PressOnTM Electrode Array with Extension Cable and Positioning Device (21 Electrodes) FDA UDI
Model / Reference
DHP102121 FDA UDI
Description
2 electrode arrays, 7mm diameter PressOnTM Electrode Array with Extension Cable and Positioning Device (21 Electrodes) FDA UDI

Identifiers

Primary DI / UDI-DI
00816312023077 FDA UDI
FDA Product Code
GXZ FDA UDI
GMDN Term
Electroencephalographic electrode cap, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electroencephalographic electrode cap, single-use

Rhythmlink® by Rhythmlink International, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic electrode cap, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhythmlink International, LLC

Sources (1)

  • FDA UDI 7e7f34c1-440d-499e-a6b0-32c4ca7cd1d8 34 fields · synced Jun 9, 2026