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Spacelabs Healthcare

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Spacelabs Healthcare FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording support kit FDA UDI
Device Name
4-ELECTRODE HOOK UP KIT WITH POUCH FDA UDI
Model / Reference
Patient cables & ECG leadwires FDA UDI
Description
4-ELECTRODE HOOK UP KIT WITH POUCH FDA UDI

Identifiers

Catalog Number
50-0049 FDA UDI
Primary DI / UDI-DI
10841522125478 FDA UDI
FDA Product Code
MWJ FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording support kit FDA UDI

Classification

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

Clinical & Handling

Sterile

No

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

Yes

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

Yes

FDA UDI

Category: Electrocardiographic long-term ambulatory recording support kit

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

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording support kit.

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 a77b7d85-192c-4c36-a50e-6f58ef3fac86 35 fields · synced Jun 8, 2026