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AriaTele

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
AriaTele FDA UDI
Generic Name
Electrocardiography telemetric monitoring system transmitter FDA UDI
Device Name
OPTION A, ECG TRANSMITTER, W/O DISPLAY, LOANER FDA UDI
Model / Reference
96281 FDA UDI
Description
OPTION A, ECG TRANSMITTER, W/O DISPLAY, LOANER FDA UDI

Identifiers

Catalog Number
L-96281-A05J FDA UDI
Primary DI / UDI-DI
10841522107849 FDA UDI
510(k) Number
K121480 FDA UDI
FDA Product Code
MHX FDA UDI
GMDN Term
Electrocardiography telemetric monitoring system transmitter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
Commercial Distribution
Not 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K121480 also covers:

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 a47a5bb0-15fd-4488-99b2-296c4b6575b8 37 fields · synced May 30, 2026