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Avive AED with Avive Connect

FDA UDI

Class III (US FDA UDI)

by Avive Solutions, Inc.

Identity

Trade Name
Avive AED with Avive Connect FDA UDI
Generic Name
Rechargeable public automated external defibrillator FDA UDI
Model / Reference
AED01 FDA UDI

Identifiers

Primary DI / UDI-DI
00860002508559 FDA UDI
PMA Number
P210015 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Rechargeable public automated external defibrillator FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 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

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

Yes

FDA UDI

Category: Rechargeable public automated external defibrillator

Avive AED with Avive Connect by Avive Solutions, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rechargeable public automated external defibrillator.

Cleared under the same submission

P210015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avive Solutions, Inc.

Sources (1)

  • FDA UDI d9690f6e-54df-4965-a21f-8ec9aea666bd 33 fields · synced May 30, 2026