Chroma2 5 Lead Patient Cable

FDA UDI

Class II (US FDA UDI)

by Scottcare Corporation, The

Identity

Trade Name: Chroma2 5 Lead Patient Cable FDA UDI
Generic Name: Electrocardiograph, professional, multichannel FDA UDI
Device Name: 5 lead ECG patient cable to be used with the Chroma2 device. FDA UDI
Model / Reference: Chroma2 5 Lead Patient Cable FDA UDI
Description: 5 lead ECG patient cable to be used with the Chroma2 device. FDA UDI

Identifiers

Primary DI / UDI-DI: 00856298006091 FDA UDI
510(k) Number: K083382 FDA UDI
FDA Product Code: DRG FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2910 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

Yes

FDA UDI

Category: Electrocardiograph, professional, multichannel

Chroma2 5 Lead Patient Cable by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K083382 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

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Manufacturer

Manufacturer: Scottcare Corporation, The

Sources (1)

FDA UDI 13be01bb-9cb6-4fb3-83a7-020c618f5f39 35 fields · synced May 30, 2026