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prolaio Cloud

FDA UDI

Class I (US FDA UDI)

by Prolaio, Inc.

Identity

Trade Name
prolaio Cloud FDA UDI
Generic Name
Electrocardiography monitoring system receiver FDA UDI
Device Name
prolaio medical device data system cloud FDA UDI
Model / Reference
DP-21-03 FDA UDI
Description
prolaio medical device data system cloud FDA UDI

Identifiers

Primary DI / UDI-DI
00850071330014 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Electrocardiography monitoring system receiver FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiography monitoring system receiver

prolaio Cloud by Prolaio, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiography monitoring system receiver.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prolaio, Inc.

Sources (1)

  • FDA UDI 4d123c1e-a894-4ac4-bdcf-0b0a04de6190 34 fields · synced May 29, 2026