FDA UDI
In Commercial Distribution
🇺🇸 United States
Terumo® Advanced Perfusion System 1
DI: 00886799001387
·
Model: 816572
·
Terumo Cardiovascular Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Terumo® Advanced Perfusion System 1
- Primary DI
- 00886799001387
- Version / Model
- 816572
- Catalog Number
- 816572
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2af4b7dd-5c24-4b09-bf3c-3cdf6f9006f8
Device Description
The centrifugal control unit provides the local display and control mechanism for the centrifugal motor and disposable pump and serves as the interface between the centrifugal motor and the rest of the system. The local display indicates the motor speed, flow rate, and safety, status and error messages. The pump can be controlled from either the CCM or from the control knob on the control unit.
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 |
|---|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | Cardiovascular | 870.4220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33317 | Cardiopulmonary bypass system centrifugal pump drive unit | A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886799001387 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151349 | 000 |