FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Probe™
DI: 00643169630642
·
Model: CB4627
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bio-Probe™
- Primary DI
- 00643169630642
- Version / Model
- CB4627
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6d14ee53-0a6c-45f0-8999-84f45e470749
Device Description
CON PROBE CB4627 BIOACT FLOW PEDIAT 10PK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 31657 | Blood flowmeter transducer, non-indwelling | A device designed to be used together with a blood flowmeter for the continuous external (extravascular) measurement of a patient's blood flow. It may measure the blood flow either in a closed chamber that encompasses the transducer outside of the body or over the outside of a blood vessel (formed as an open circle which is slid over the vessel, having different diameters to fit different size blood vessels). It may function by using ultrasound or electromagnetic (EM) technologies. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20643169802678 | GS1 | PK | 10 | In Commercial Distribution | |
| Primary | 00643169630642 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132730 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.35 MM Port Outer Diameter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use alcohol or alcohol-based fluids on any surface of this device.
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius