ReviveR Pro Configuration

GUDID 10815098020260

DEFIBTECH, L.L.C.

Non-rechargeable professional semi-automated external defibrillator
Primary Device ID10815098020260
NIH Device Record Key5fbcaabe-25b3-4312-9c11-ff5927ebafa0
Commercial Distribution Discontinuation2024-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameReviveR Pro Configuration
Version Model NumberDDU-C2400
Company DUNS128340200
Company NameDEFIBTECH, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815098020260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-03-26
Device Publish Date2015-10-24

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