FDA.reportPublic FDA data

ProtekDuo

Primary DI
00814112020548
Brand
ProtekDuo
Company
CARDIACASSIST, INC.
Model
5720-3631
Device description
TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula
Published
2018-10-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DREDilator, Vessel, For Percutaneous Catheterization
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller TypeCardiovascular2
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020548008141120205488141120205480814112020548

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003737421gjohnson@tandemlife.com
+14129637770gjohnson@tandemlife.com

Regulatory Flags#

DUNS number
948683941
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814112020166PROTEK Duo5140-46292015-10-10
00814112020319ProtekDuo5140-51312016-09-23
00814112020067TandemHeart5140-62212015-10-10
00814112020098TandemHeart5140-62172015-10-10
00814112020104TandemHeart5130-17175130-17172015-10-10
00814112020111TandemHeart5130-17155130-17152015-10-10
00814112020449ProtekSolo5140-60245140-60242017-01-27
00814112020456ProtekDuo5100-14262017-05-22
00814112020623LifeSPARC5900-00012020-05-27
00814112020630LifeSPARC5900-00022020-05-27
00814112020692TandemLife LifeSPARC5840-24172020-06-01
00814112020906LifeSPARC5900-00125900-00122022-05-10
00814112020609LifeSPARC5800-10002020-05-29
00814112020685TandemLife LifeSPARC5840-00002020-05-29
00814112020753TandemLung LifeSPARC5830-29162020-05-29
00814112020760TandemLung LifeSPARC5830-31182020-05-29
00814112020777TandemLung LifeSPARC5830-36312020-05-29
00814112020814LifeSPARC5800-10012020-05-29
00814112020562LifeSPARC5900-00002019-12-18
00814112020579LifeSPARC5900-00032019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
00824846005445NAMEDTRONIC, INC.DWF2026-07-30
00824846005469NAMEDTRONIC, INC.DWF2026-07-30
00824846005667NAMEDTRONIC, INC.DWF2026-07-30
00824846006022NAMEDTRONIC, INC.DWF2026-07-30
00824846007944NAMEDTRONIC, INC.DWF2026-07-30
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25