FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FloProbe 3/8’’ x 3/8” (Non Sterile)
DI: 10814321020176
·
Model: 3080N
·
INTERNATIONAL BIOPHYSICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- FloProbe 3/8’’ x 3/8” (Non Sterile)
- Primary DI
- 10814321020176
- Version / Model
- 3080N
- Company Name
- INTERNATIONAL BIOPHYSICS CORPORATION
- Labeler DUNS
- 788403103
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-07-12
- Public Version
- 5
- Public Version Date
- 2021-12-28
- Public Version Status
- Update
- Public Device Record Key
- 38c87b31-b8a3-4de7-915d-c4375df09b9c
- Distribution End Date
- 2021-12-27
Device Description
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | Cardiovascular | 870.2120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10431 | Electromagnetic blood flowmeter | A device using electromagnetic (EM) technology to provide a method of confirming and measuring the velocity of blood flow in vessels after coronary artery bypass, organ transplant, and other vascular reconstructive surgery. It uses an invasive technique that is performed with either a catheter inserted into a vessel or with a probe that surrounds a surgically exposed vessel without penetrating the vessel wall. Also known as an EM flowmeter. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10814321020176 | GS1 | ||||
| Unit of Use | 00814321020179 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963703 | 000 |