FDA.report

PEMCO INC

Primary DI
B1521580F044MM900
Brand
PEMCO INC
Company
PEMCO INC
Model
1580-F-04-4MM-90
Catalog number
1580-F-04-4MM-90
Device description
Perfusion Cannula. Flag Handle 6.5 inches long. Style # 4 Fixed Tip with side holes - 4 MM Tip Diameter. 90 Degree Bend. Also available in: Large,
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B1521580F044MM900PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Angle90degree
Length6.5Inch
Outer Diameter4Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
12165242990info@pemcomed.com

Regulatory Flags

DUNS number
004217071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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