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ReviveR Pro

FDA UDI

Class III (US FDA UDI)

by Defibtech, L.l.c.

Identity

Trade Name
ReviveR Pro FDA UDI
Generic Name
Non-rechargeable professional semi-automated external defibrillator FDA UDI
Model / Reference
DDU-C2400 FDA UDI

Identifiers

Primary DI / UDI-DI
00815098020263 FDA UDI
510(k) Number
K121853 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Non-rechargeable professional semi-automated external defibrillator FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 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

ReviveR Pro by Defibtech, L.l.c. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121853 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Defibtech, L.l.c.

Sources (1)

  • FDA UDI 531dd7ee-2b47-4d0d-abf1-ad1e74d7c24b 34 fields · synced May 30, 2026