FDA.report

Bio-Medicus™

Primary DI
00763000193553
Brand
Bio-Medicus™
Company
MEDTRONIC, INC.
Model
CB96825-012
Device description
CANNULA CB96825-012 BIO-MEDICUS 12FR
Published
2019-03-06
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

Related Records

Contact Domains

Product Codes

CodeName
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000193553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000193553007630001935537630001935530763000193553

GMDN Terms

TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge12French
Length10Centimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Store the product at room temperature.

Sterilization Methods

Method

Contacts

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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