FDA UDI
In Commercial Distribution
🇺🇸 United States
Daily Cardiac Cooling Jacket
DI: 00867673000306
·
Model: C1116, C1123, C1130
·
DAILY MEDICAL PRODUCTS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Daily Cardiac Cooling Jacket
- Primary DI
- 00867673000306
- Version / Model
- C1116, C1123, C1130
- Company Name
- DAILY MEDICAL PRODUCTS, INC
- Labeler DUNS
- 800432093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-02
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1efed18e-934b-4c45-b5f4-76c000b04b68
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWC | Controller, Temperature, Cardiopulmonary Bypass | Cardiovascular | 870.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35973 | Cardiac insulation pad | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00867673000306 | GS1 |
Customer Contacts
- Phone
- 763-550-1775
- [email protected]