Trackit Sleepwalker

FDA UDI

Class II (US FDA UDI)

by Lifelines Limited

Identity

Trade Name: Trackit Sleepwalker FDA UDI
Generic Name: Polysomnograph FDA UDI
Model / Reference: MK3 + SaO2 FDA UDI

Identifiers

Catalog Number: 1302 FDA UDI
Primary DI / UDI-DI: 05060275450134 FDA UDI
510(k) Number: K010460 FDA UDI
FDA Product Code: OLV FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 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

Category: Polysomnograph

Trackit Sleepwalker by Lifelines Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cadwell — Cadwell Industries, Inc. · Class II

Cleared under the same submission

K010460 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: Lifelines Limited

Sources (1)

FDA UDI d1d6b846-1db9-43f4-a9f1-6ebc0a3c0806 35 fields · synced May 30, 2026