FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FloPump
DI: 00814321020100
·
Model: 1/4" FloPump/FloProbe Kit (Sterile)
·
INTERNATIONAL BIOPHYSICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FloPump
- Primary DI
- 00814321020100
- Version / Model
- 1/4" FloPump/FloProbe Kit (Sterile)
- Catalog Number
- 6300S(KIT)
- Company Name
- INTERNATIONAL BIOPHYSICS CORPORATION
- Labeler DUNS
- 788403103
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-09
- Public Version
- 5
- Public Version Date
- 2021-12-14
- Public Version Status
- Update
- Public Device Record Key
- 30859ff6-1209-40f2-b07c-37d75eef81df
- Distribution End Date
- 2021-12-13
Device Description
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Cardiovascular | 870.4360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31718 | Cardiopulmonary bypass system centrifugal pump | A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814321020100 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983272 | 000 |