ReviveR Auto Configuration

GUDID 10815098020062

DEFIBTECH, L.L.C.

Non-rechargeable public automated external defibrillator
Primary Device ID10815098020062
NIH Device Record Keyc81a355d-4518-46ea-96bc-13d6b7af55ea
Commercial Distribution Discontinuation2024-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameReviveR Auto Configuration
Version Model NumberDDU-120B
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
GS110815098020062 [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

Devices Manufactured by DEFIBTECH, L.L.C.

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10815098020062 - ReviveR Auto Configuration2025-03-26
10815098020062 - ReviveR Auto Configuration2025-03-26
10815098020222 - ReviveR View Configuration2025-03-26
10815098020260 - ReviveR Pro Configuration2025-03-26
10815098020307 - ReviveR ECG Configuration2025-03-26
10815098020475 - DDU-1XX Series Adult Pads Adapter, Physio-Control Configuration2024-06-06
10815098020482 - DDU-1XX Series Adult Pads Adapter, Zoll Configuration2024-06-06
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