FDA UDI
In Commercial Distribution
🇺🇸 United States
VitalFlow Caddy
DI: 10850007732353
·
Model: 58120
·
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VitalFlow Caddy
- Primary DI
- 10850007732353
- Version / Model
- 58120
- Catalog Number
- 58120
- Company Name
- MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- Labeler DUNS
- 806687406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-19
- Public Version
- 1
- Public Version Date
- 2024-09-27
- Public Version Status
- New
- Public Device Record Key
- d22084cf-4398-4459-bb72-97e3259fb214
Device Description
The VitalFlow Caddy is a holder for the VitalFlow motor drive (Model 58102), VitalFlow emergency handcrank (Model 58103), and Nautilus™ VF ECMO oxygenator with Balance™ Biosurface (Model 58110).
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | Cardiovascular | 870.4200 | 1 |
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 | 10850007732353 | GS1 |