Cardiac Insulation Pad

GUDID 10803622131889

LIVANOVA USA, INC.

Cardiac insulation pad
Primary Device ID10803622131889
NIH Device Record Key31018375-812c-4eb9-b033-4f0ec0c47160
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiac Insulation Pad
Version Model NumberCIPA
Company DUNS080914995
Company NameLIVANOVA USA, INC.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622131882 [Primary]
GS110803622131889 [Package]
Contains: 00803622131882
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-15
Device Publish Date2016-05-13

On-Brand Devices [Cardiac Insulation Pad]

10803622131896CIPI
10803622131889CIPA

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