FDA UDI
In Commercial Distribution
🇺🇸 United States
Sarns™ Modular Perfusion System 8000
DI: 00886799000199
·
Model: 16404
·
Terumo Cardiovascular Systems Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sarns™ Modular Perfusion System 8000
- Primary DI
- 00886799000199
- Version / Model
- 16404
- Catalog Number
- 16404
- 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
- c6171778-86dc-4276-8010-2abcce5562cd
Device Description
8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection 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 |
|---|---|---|---|---|
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | Cardiovascular | 870.4340 | 2 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | Cardiovascular | 870.4205 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35440 | Cardiopulmonary bypass system air bubble/fluid level detector | A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886799000199 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915183 | 000 |