DDU-1XX Series Adult Pads Adapter, Physio-Control Configuration

GUDID 10815098020475

DEFIBTECH, L.L.C.

Electrocardiographic lead set, reusable
Primary Device ID10815098020475
NIH Device Record Keyb9751e56-99cf-4d1b-8f6b-b353fbcce51f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDDU-1XX Series Adult Pads Adapter, Physio-Control Configuration
Version Model NumberDAC-300E
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 Batchtrue
Serial Numberfalse
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
GS110815098020475 [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 Date2024-06-06
Device Publish Date2015-10-23

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