Bio-Probe™

Primary DI
20763000419909
Brand
Bio-Probe™
Company
MEDTRONIC, INC.
Model
CB4627
Device description
PROBE CB4627 BIOACT FLOW PED 10PK
Published
2021-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132730000BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACEMedtronic, Inc.2014-05-30DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000419909PackageGS110In Commercial Distribution
00763000419905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300041990920763000419909
00763000419905007630004199057630004199050763000419905

GMDN Terms#

Term, Definition table
TermDefinition
Blood flowmeter transducer, non-indwellingA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.35Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Do not use alcohol or alcohol-based fluids on any surface of this device.
Special Storage Condition, Specify00Store the product at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000419899Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
00763000419905Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
20763000419893Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
15060484490157moorFLPI-2 Clinical PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2018-12-13
00643169630635Bio-Probe™MEDTRONIC, INC.DPT2017-01-22
00643169630642Bio-Probe™MEDTRONIC, INC.DPT2017-01-21
10351688507990MedexICU MEDICAL, INC.DPT2016-12-30
10351688508669MedexICU MEDICAL, INC.DPT2016-12-30
10351688516916MedexICU MEDICAL, INC.DPT2016-12-30
50351688508667MedexICU MEDICAL, INC.DPT2016-12-30
50351688516914MedexICU MEDICAL, INC.DPT2016-12-30
10351688503060MedexICU MEDICAL, INC.DPT2016-12-29
10351688505187MedexICU MEDICAL, INC.DPT2016-12-29
10351688505743MedexICU MEDICAL, INC.DPT2016-12-29
50351688505741MedexICU MEDICAL, INC.DPT2016-12-29
10351688503008MedexICU MEDICAL, INC.DPT2016-12-13
50351688503006MedexICU MEDICAL, INC.DPT2016-12-13
10351688503619MedexICU MEDICAL, INC.DPT2016-12-07
10351688503671MedexICU MEDICAL, INC.DPT2016-12-07
10351688503718MedexICU MEDICAL, INC.DPT2016-12-07
10351688503794MedexICU MEDICAL, INC.DPT2016-12-07
50351688503792MedexICU MEDICAL, INC.DPT2016-12-07
15060484490119moorFLPI-2 Review PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
15060484490126moorFLPI2- Measurement PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
10351688508416MedexICU MEDICAL, INC.DPT2016-10-19
10351688508423MedexICU MEDICAL, INC.DPT2016-10-19
10351688508560MedexICU MEDICAL, INC.DPT2016-10-19
10351688508775MedexICU MEDICAL, INC.DPT2016-10-19
10351688508782MedexICU MEDICAL, INC.DPT2016-10-19
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