FDA.reportPublic FDA data

Pediatric Heart Cooling Jacket

Primary DI
16641670001341
Brand
Pediatric Heart Cooling Jacket
Company
Cardiomed Supplies Inc
Model
2.0
Catalog number
17-262
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
36641670001352PrimaryGS10
16641670001341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167000135236641670001352
1664167000134116641670001341

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
240623124
Device count
18
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36641670001314Adult Heart Cooling Jacket2.417-2602021-04-21
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30
00199150083800NAMEDTRONIC, INC.DWF2026-05-30
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11