FDA UDI
In Commercial Distribution
🇺🇸 United States
CDI OneView™ Monitoring System
DI: 00886799001936
·
Model: CDI771
·
Terumo Cardiovascular Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CDI OneView™ Monitoring System
- Primary DI
- 00886799001936
- Version / Model
- CDI771
- Catalog Number
- CDI771
- 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
- db8c96a6-3167-4f60-83e5-345d671a40f2
Device Description
CDI OneView™ EDM DMS Interface Module
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 |
|---|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Cardiovascular | 870.4330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36862 | Patient monitoring system module, interfacing | A small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886799001936 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234065 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 104 Degrees Fahrenheit