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Lifecard

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Lifecard FDA UDI
Generic Name
Electrocardiographic ambulatory recorder FDA UDI
Device Name
PACKAGE, LIFECARD CF AND PATHFINDER SL FDA UDI
Model / Reference
Lifecard FDA UDI
Description
PACKAGE, LIFECARD CF AND PATHFINDER SL FDA UDI

Identifiers

Catalog Number
040-1760-00 FDA UDI
Primary DI / UDI-DI
10841522127212 FDA UDI
FDA Product Code
MWJ FDA UDI
DQK FDA UDI
DXH FDA UDI
GMDN Term
Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 FDA UDI
870.1425 FDA UDI
870.2920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic ambulatory recorderElectrocardiographic long-term ambulatory recording analyserCardiology information system application software

Lifecard by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiology information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI 7041dbc1-3f1b-41e8-8c84-0ed36448c1be 34 fields · synced Jun 1, 2026