Heart-Chill Cardiac & Phrenic Insulator

GUDID B040CPIL25

Cardiac & Phrenic Insulator

GENESEE BIOMEDICAL, INC.

Cardiac insulation pad
Primary Device IDB040CPIL25
NIH Device Record Keyed4476fd-3fa8-4c3e-b9f8-9c64ec797fbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeart-Chill Cardiac & Phrenic Insulator
Version Model NumberCPI-L
Company DUNS939872651
Company NameGENESEE BIOMEDICAL, INC.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 7864890
Emailinfo@geneseebiomedical.com
Phone800 7864890
Emailinfo@geneseebiomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040CPIL14 [Primary]
HIBCCB040CPIL25 [Package]
Contains: B040CPIL14
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWCController, Temperature, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-01

On-Brand Devices [Heart-Chill Cardiac & Phrenic Insulator]

B040CPIS1Cardiac & Phrenic Insulator
B040CPIL25Cardiac & Phrenic Insulator

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