FDA.reportPublic FDA data

PRO-FUSE®

Primary DI
50884908149697
Brand
PRO-FUSE®
Company
Medical Components, Inc.
Model
MIPP80AFS
Catalog number
MIPP80AFS
Device description
8F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER W/5F MICRO-STICK® INTRODUCER SET
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908149697PackageGS15In Commercial Distribution
00884908149692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490814969750884908149697
00884908149692008849081496928849081496920884908149692

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port/catheterA fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags#

DUNS number
038000253
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50884908183912SLX Hemo-Cath®MC061405MC0614052026-03-21
50884908183943SLX Hemo-Cath®MC061404MC0614042026-03-21
50884908187620SLX Hemo-Cath®MC061424MBMC061424MB2026-03-21
50884908187637SLX HEMO-CATH®MC061425MBMC061425MB2026-03-21
30884908188456MICRO-STICK SETDMRAH190411DMRAH1904112026-02-19
30884908188463MICRO-STICK SETDMRAH190421DMRAH1904212026-02-19
50884908188474MICRO-STICK SETDMRAH190511DMRAH1905112026-02-19
50884908188481MICRO-STICK SETDMRAH190521DMRAH1905212026-02-19
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28036301MD280363012026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037201MD280372012026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037101MD280371012026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)MR28036304MR280363042026-02-17
50884908152703PRO-PICC® CTMD17035201MD170352012026-02-17
50884908154714PRO-PICC® CTMD17036201MD170362012026-02-17
50884908154721PRO-PICC® CTMD17036301MD170363012026-02-17
50884908160234PRO-PICC® CTMD17035101MD170351012026-02-17
50884908160258PRO-PICC® CTMD17034101MD170341012026-02-17
50884908174361PRO-PICC® CTMD17035105MD170351052026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMD17013101MD170131012026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMD17013105MD170131052026-02-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007435VYGONVygon CorporationLJT2026-05-22
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13661234027450PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027467PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027474PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
13661234027481PEROUSE MEDICALPEROUSE MEDICALLJT2026-01-22
10610586032660ICU Medical, Inc.ICU MEDICAL, INC.LJT2026-01-05
10801741232401AllPoints Port Access System PowerLocBard Access Systems, Inc.LJT2024-12-05
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15051684018753BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018777BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018784BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018807XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018821XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018845XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018852XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018869XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018876XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018890XcelaAngiodynamics, Inc.LJT2024-09-20
15051684017985Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018005Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018081Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018098Smart Port CTAngiodynamics, Inc.LJT2024-07-23