FDA.reportPublic FDA data

Daily Cardiac Cooling Jacket

Primary DI
00867673000306
Brand
Daily Cardiac Cooling Jacket
Company
DAILY MEDICAL PRODUCTS, INC
Model
C1116, C1123, C1130
Device description
The Daily Cardiac Cooling Jacket is a conformable heat exchanger which is placed around the heart during cardiopulmonary bypass procedures. By circulating cold physiologic saline through the jacket the heat is transferred from the heart to the solution thus reducing the heart temperature to provide myocardial preservation. The device is used as an alternative to iced slush for topical cardiac hypothermia.
Published
2017-03-02
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867673000306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867673000306008676730003068676730003060867673000306

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
763-550-1775xxx@xx.xx

Regulatory Flags#

DUNS number
800432093
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850054036261CardioQuip Dripless Hose Set 10' 90 Connectors and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036278CardioQuip Dripless Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036285CardioQuip Dripless Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036292CardioQuip Dripless Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036308CardioQuip Dripless Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036315CardioQuip Dripless End SetCARDIOQUIP, LLCDWC2025-10-27
00850054036322CardioQuip Dripless End Set with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036339"CardioQuip Oxygenator Connector, Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036346"CardioQuip Oxygenator Connector. Straight, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036353"CardioQuip Main/CPG Connector. Male. Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036360CardioQuip Standard Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036377CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036384CardioQuip Standard Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036391CardioQuip Standard Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036407CardioQuip Standard Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036414CardioQuip Standard Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036421CardioQuip Dripless Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036438CardioQuip Dripless Hose Set 6' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036445CardioQuip Standard Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036452CardioQuip Standard Hose Set 6' with Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036605CardioQuip Mini wheel SetCARDIOQUIP, LLCDWC2025-10-27
05060434422460QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422477QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422484QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422491QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434423757QuantumSPECTRUM MEDICAL LIMITEDDWC2022-06-09
05060434420961QuantumSPECTRUM MEDICAL LIMITEDDWC2022-05-18
00860000846103CardioQuip Modular Cooler-Heater (MCH)CARDIOQUIP, LLCDWC2020-12-08
00860000846110CardioQuip Modular Cooler-Heater (MCH)CARDIOQUIP, LLCDWC2020-12-08