FDA.reportPublic FDA data

Adult Heart Cooling Jacket

Primary DI
36641670001314
Brand
Adult Heart Cooling Jacket
Company
Cardiomed Supplies Inc
Model
2.4
Catalog number
17-260
Device description
The Heart Cooling Jacket is effective in controlling the temperature of the cardiac organ during an open heart surgery. The closed loop heat transfer system works to protect the cardiac organ.
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833112000TUBING FOR CARDIOPULMONARY BYPASSCardio Med Supplies, Inc.1983-11-28DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36641670001314PrimaryGS10
16641670001303Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167000131436641670001314
1664167000130316641670001303

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac arrest hypothermia kitA collection of devices intended to lower the core body temperature of a patient in the short term following a cardiac arrest event to induce and sustain mild hypothermia for improvement of neurological and cognitive prognoses. It typically includes blankets, caps, axilla pads and groin pads, which are filled with a thermally-retentive material (e.g., non-toxic polymer gel) that can be cooled in a freezer. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Regulatory Flags#

DUNS number
240623124
Device count
18
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36641670001338Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
36641670001352Pediatric Heart Cooling Jacket2.017-2622021-04-21
36641670011528rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
36641670019241Drop-It™ Quick Release Needle Holders1.145502021-04-21
16641670001303Adult Heart Cooling Jacket2.417-2602021-04-21
16641670001327Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
16641670001341Pediatric Heart Cooling Jacket2.017-2622021-04-21
16641670011517rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
16641670019230Drop-It™ Quick Release Needle Holders1.145502021-04-21
366416700041793/8'' x 1/4'' x 3/8'' Y Connector2.9C-6602020-12-02
366416700041931/2'' x 3/8'' x 3/8'' Y Connector2.8C-6612020-12-02
366416700042163/8'' x 1/4'' x 1/4'' Y Connector2.0C-6622020-12-02
366416700042301/2'' x 3/8'' x 1/2'' Y Connector2.4C-6632020-12-02
366416700042541/4'' Y Connector w/L.L.2.6C-6642020-12-02
366416700042783/8'' Y Connector w/L.L.2.6C-6652020-12-02
366416700042921/2'' Y Connector w/L.L.1.4C-6662020-12-02
366416700043153/16'' Y Connector w/L.L.1.5C-6672020-12-02
366416700043393/8'' x 1/4'' x 3/8'' Y Connector w/L.L.1.3C-6682020-12-02
366416700043531/2'' x 3/8'' x 3/8'' Y Connector w/L.L.1.6C-6692020-12-02
366416700043773/8'' x 1/2'' x 1/2'' Y Connector w/L.L.2.3C-6702020-12-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033178019651Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
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08033178019675Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
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08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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08033178019071Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019088Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
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