FDA UDI
In Commercial Distribution
🇺🇸 United States
CDI OneView™ Monitoring System
DI: 10886799001865
·
Model: CDI746
·
Terumo Cardiovascular Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CDI OneView™ Monitoring System
- Primary DI
- 10886799001865
- Version / Model
- CDI746
- Catalog Number
- CDI746
- Company Name
- Terumo Cardiovascular Systems Corporation
- Labeler DUNS
- 177655466
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-23
- Public Version
- 1
- Public Version Date
- 2024-07-31
- Public Version Status
- New
- Public Device Record Key
- 10261e94-ad95-49c9-a59a-6c1bd1863e1b
Device Description
CDI OneView™ Calibration Gas 1
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Cardiovascular | 870.4330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35441 | Cardiopulmonary bypass system blood tubing set | A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886799001865 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234065 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 64.4 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius