FDA UDI
In Commercial Distribution
🇺🇸 United States
HX2™ Temperature Management System
DI: 00886799000908
·
Model: 809883
·
Terumo Cardiovascular Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HX2™ Temperature Management System
- Primary DI
- 00886799000908
- Version / Model
- 809883
- Catalog Number
- 809883
- Company Name
- Terumo Cardiovascular Systems Corporation
- Labeler DUNS
- 177655466
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 5
- Public Version Date
- 2019-12-23
- Public Version Status
- Update
- Public Device Record Key
- ea5f74c4-7a6a-4688-b2cc-472e1d1ded91
Device Description
HX2 Temperature Control System Accessory Hose Kit
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
- No
- Has Lot/Batch Number
- Yes
- 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 | 00886799000908 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071521 | 000 |