Defibtech AirAware Remote ASI Cellular Module

GUDID 10815098020703

DEFIBTECH, L.L.C.

Computer network router Computer network router
Primary Device ID10815098020703
NIH Device Record Key669fddc4-3996-43dd-8b1b-a2037a987f40
Commercial Distribution StatusIn Commercial Distribution
Brand NameDefibtech AirAware Remote ASI Cellular Module
Version Model NumberDCM-U1613
Company DUNS128340200
Company NameDEFIBTECH, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
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
GS100815098020706 [Primary]
GS110815098020703 [Package]
Contains: 00815098020706
Package: [1 Units]
In Commercial Distribution

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-09
Device Publish Date2018-12-24

Devices Manufactured by DEFIBTECH, L.L.C.

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