FDA.report

CT POWER INJECTABLE IMPLANTABLE INFUSION PORTCT POWER INJECTABLE IMPLANTABLE INF

Primary DI
50884908148317
Brand
CT POWER INJECTABLE IMPLANTABLE INFUSION PORTCT POWER INJECTABLE IMPLANTABLE INF
Company
Medical Components, Inc.
Model
MICTI50041MP
Catalog number
MICTI50041MP
Device description
5F PLASTIC DIGNITY® MINI PROFILE CT PORTMINI PROFILE W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER W/5FPOLYUR Micro-Stick®INTRODUCER SE
Published
2019-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50884908148317PackageGS15In Commercial Distribution
00884908148312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490814831750884908148317
00884908148312008849081483128849081483120884908148312

GMDN Terms

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

Contacts

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

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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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