FDA UDI
In Commercial Distribution
🇺🇸 United States
Sarns™ Modular Perfusion System 8000
DI: 00886799000205
·
Model: 16413
·
Terumo Cardiovascular Systems Corporation
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sarns™ Modular Perfusion System 8000
- Primary DI
- 00886799000205
- Version / Model
- 16413
- Catalog Number
- 16413
- 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
- 6187842a-cc60-4ad8-bb6f-21b4e7c52a5a
Device Description
8000 Perfusion System Arterial Monitor Providing Temperature and Pressure Measurement Display.
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 |
|---|---|---|---|---|
| 36374 | Cardiopulmonary bypass system temperature control unit | An electronic device that is a module of a cardiopulmonary bypass system and that is used to measure and display the temperatures of the different temperature probes that are connected into the total system in order to monitor the fluid and blood temperatures at various points. It may also control the temperature levels, e.g., the temperature level of the fluid entering and leaving the heat exchanger. | No | Active |
| 36356 | Cardiopulmonary bypass system pressure monitor | A mains electricity (AC-powered) device used to electronically measure the pressure in a cardiopulmonary bypass system (e.g., in the extracorporeal tubing circuit); it may provide an alarm if pressure levels exceed operator-set limits. It is typically a module of the heart-lung bypass system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886799000205 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915183 | 000 |