FDA UDI
In Commercial Distribution
🇺🇸 United States
CardioQuip Modular Cooler-Heater (MCH)
DI: 00860000846110
·
Model: MCH-1000(m)
·
CARDIOQUIP, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CardioQuip Modular Cooler-Heater (MCH)
- Primary DI
- 00860000846110
- Version / Model
- MCH-1000(m)
- Company Name
- CARDIOQUIP, LLC
- Labeler DUNS
- 144183733
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-08
- Public Version
- 1
- Public Version Date
- 2020-12-16
- Public Version Status
- New
- Public Device Record Key
- 7f225b90-69bd-4e66-be6b-5ec43ada2388
Device Description
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 17206 | Cardiopulmonary bypass system heating/cooling unit | A mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860000846110 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102147 | 000 |