ACC Patient Interface Pad

GUDID 00815098020584

DEFIBTECH, L.L.C.

Cardiac resuscitator, line-powered
Primary Device ID00815098020584
NIH Device Record Key5c0f600d-19b7-46ef-8632-84fb7d27068b
Commercial Distribution StatusIn Commercial Distribution
Brand NameACC Patient Interface Pad
Version Model NumberRPP-G1000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100815098020584 [Primary]
GS120815098020588 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRMCompressor, Cardiac, External

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

Devices Manufactured by DEFIBTECH, L.L.C.

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10815098020017 - Lifeforce Configuration2025-07-10
10815098020055 - Lifeforce Auto Configuration2025-07-10
10815098020406 - DDU-1XXX/2XXX Series Rechargeable Battery Pack Configuration2025-07-10
10815098020819 - Defibtech ARM XR Compression Module Configuration2025-04-02
10815098020024 - ReviveR Configuration2025-03-26
10815098020062 - ReviveR Auto Configuration2025-03-26

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