FDA.reportPublic FDA data

Heart-Chill Cardiac & Phrenic Insulator

Primary DI
B040CPIS1
Brand
Heart-Chill Cardiac & Phrenic Insulator
Company
GENESEE BIOMEDICAL, INC.
Model
CPI-S
Device description
Cardiac & Phrenic Insulator
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWCController, Temperature, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874927000PTI HEART-CHILL(TM) CARDIAC INSULATING JACKETPioneering Technologies, Inc.1988-01-29DWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040CPIS2PackageHIBCC1In Commercial Distribution
B040CPIS1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac insulation padA thin and pliable cushion designed to be placed around the heart in conjunction with cold cardioplegia during cardiac surgery with extracorporeal circulation. The device is intended to help to prevent rapid rewarming of the heart. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 786-4890info@geneseebiomedical.com

Regulatory Flags#

DUNS number
939872651
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B040RPS181100Thoracic Port with Obturator 18x110mmRPS-181102026-03-25
B040RPS18500Thoracic Port with Obturator 18x50mmRPS-18502026-03-25
B040RPS18700Thoracic Port with Obturator 18x70mmRPS-18702026-03-25
B040RPS18900Thoracic Port with Obturator 18x90mmRPS-18902026-03-25
B040TF260TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF280TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF300TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF320TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF340TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF380TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF400TransForm McCarthy Annuloplasty RingTF-402024-12-23
B040TF240TransForm McCarthy Annuloplasty RingTF-242024-12-23
B040TF26TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF28TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF30TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF32TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF34TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF360TransForm McCarthy Annuloplasty RingTF-362024-12-23
B040TF38TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF40TransForm McCarthy Annuloplasty RingTF-402024-12-23

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