Identity
- Trade Name
- Daily Cardiac Cooling Jacket FDA UDI
- Generic Name
- Cardiac insulation pad FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- C1116, C1123, C1130 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867673000306 FDA UDI
- FDA Product Code
- DWC FDA UDI
- GMDN Term
- Cardiac insulation pad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac insulation pad
Daily Cardiac Cooling Jacket by Daily Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac insulation pad.
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- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Cardiac Insulation Pad — LivaNova USA, Inc. · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Heart-Chill Cardiac & Phrenic Insulator — GENESEE BIOMEDICAL, INC. · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Daily Medical Products, Inc.
Sources (1)
- FDA UDI 1efed18e-934b-4c45-b5f4-76c000b04b68 34 fields · synced Jun 8, 2026