FDA.reportPublic FDA data

PEMCO INC

Primary DI
B1521580A013MM00
Brand
PEMCO INC
Company
PEMCO INC
Model
1580-A-01-3MM-0
Catalog number
1580-A-01-3MM-0
Device description
Perfusion Cannula. Large Handle 8.5 inches long. Style # 1 Fixed Tip with side holes - 3 MM Tip Diameter. Zero Degree Bend.Also available in: Flag, Small, & Tube Handle Styles
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1521580A013MM00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular irrigation cannula, coronary artery, reusableA rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is typically achieved with the use of a removable stylet or trocar blade. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Length8.5Inch
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
12165242990info@pemcomed.com

Regulatory Flags#

DUNS number
004217071
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B152410028CS020RULTRACT4100-28CS-024100-28CS-022025-11-21
B152410032AS020RULTRACT4100-32AS-024100-32AS-022025-11-21
B1524150S020RULTRACT4150S-024150S-022025-11-21
B1524160S020RULTRACT4160S-024160S-022025-11-21
B152410028CS010RULTRACT4100-28CS-014100-28CS-012024-03-11
B152410032AS010RULTRACT4100-32AS-014100-32AS-012024-03-11
B1524150S010RULTRACT4150S-014150S-012024-03-11
B1524160S010RULTRACT4160S-014160S-012024-03-11
B1524100080RULTRACT4100-084100-082021-12-06
B152410012R0RULTRACT4100-12R4100-12R2021-12-06
B152410012RD0RULTRACT4100-12RD4100-12RD2021-12-06
B152410020NE0RULTRACT4100-20NE4100-20NE2021-12-06
B152410020P0RULTRACT4100-20P4100-20P2021-12-06
B152410020SP0RULTRACT4100-20SP4100-20SP2021-12-06
B152410028C0RULTRACT4100-28C4100-28C2021-12-06
B152410028CP0RULTRACT4100-28CP4100-28CP2021-12-06
B152410028CS0RULTRACT4100-28CS4100-28CS2021-12-06
B152410032A0RULTRACT4100-32A4100-32A2021-12-06
B152410032AL0RULTRACT4100-32AL4100-32AL2021-12-06
B152410032ALS0RULTRACT4100-32ALS4100-32ALS2021-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30
00199150083800NAMEDTRONIC, INC.DWF2026-05-30
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11