FDA UDI
In Commercial Distribution
🇺🇸 United States
VitalFlow Power Cord 12 V DC, 3m
DI: 10850007732308
·
Model: 58141
·
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 Power Cord 12 V DC, 3m
- Primary DI
- 10850007732308
- Version / Model
- 58141
- Catalog Number
- 58141
- 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
- 5636f8ac-596d-4bfe-b4e7-c16fb4f9f1ee
Device Description
DC Power Cord (12 V DC, 3m) for VitalFlow Console
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | Cardiovascular | 870.4100 | 2 |
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 | 10850007732308 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230364 | 000 |