FLEXI-PORT

Primary DI
00860014030826
Brand
FLEXI-PORT
Company
Portal Access, Inc.
Model
68364
Catalog number
68364
Device description
FLEXI-PORT Power Injectable Implantable Port With Attachable 5F Polyurethane Catheter Kit
Published
2026-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260916000FLEXI-PORTâ„¢ Power Injectable Implantable PortPortal Access, Inc.2026-06-17LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014030826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014030826008600140308268600140308260860014030826

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Catheter Length0

Regulatory Flags#

DUNS number
119535395
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
00860014030802FLEXI-PORT68362683622026-07-05
00860014030819FLEXI-PORT68360683602026-07-05
00860014030833FLEXI-PORT68363683632026-07-05