Bio-Probe™
GUDID 20763000419909
PROBE CB4627 BIOACT FLOW PED 10PK
MEDTRONIC, INC.
Blood flowmeter transducer, non-indwelling| Primary Device ID | 20763000419909 |
| NIH Device Record Key | a9ac0f1a-3cb9-456a-884b-750595bebe19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-Probe™ |
| Version Model Number | CB4627 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
| Outer Diameter | 6.35 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol-based fluids on any surface of this device. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000419905 [Primary] |
| GS1 | 20763000419909 [Package] Contains: 00763000419905 Package: PK [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132730
FDA Product Code
| DPT | PROBE, BLOOD-FLOW, EXTRAVASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-27 |
| Device Publish Date | 2021-09-18 |
On-Brand Devices [Bio-Probe™]
| 20643169802678 | CON PROBE CB4627 BIOACT FLOW PEDIAT 10PK |
| 20643169802661 | PROBE CB2980POLY FLOW BIOACTIVE 10PK |
| 20763000419909 | PROBE CB4627 BIOACT FLOW PED 10PK |
| 20763000419893 | PROBE CB2980POLY FLOW BIOACTIVE 10PK |
Trademark Results [Bio-Probe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIO-PROBE 73434739 1314453 Live/Registered |
Bio-Medicus, Inc. 1983-07-15 |
 BIO-PROBE 73361497 1451590 Live/Registered |
ENZO BIOCHEM, INC. 1982-04-26 |
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