Defibtech ARM XR Compression Module Configuration

GUDID 10815098020819

DEFIBTECH, L.L.C.

Cardiac resuscitator, battery-powered
Primary Device ID10815098020819
NIH Device Record Key991c9e58-1370-43c3-9748-f8a124a6c724
Commercial Distribution StatusIn Commercial Distribution
Brand NameDefibtech ARM XR Compression Module Configuration
Version Model NumberRMC-U2000
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
GS110815098020819 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by DEFIBTECH, L.L.C.

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