FDA.reportPublic FDA data

Invisiport 4.4 Fr

Primary DI
00864144000209
Brand
Invisiport 4.4 Fr
Company
STEALTH THERAPEUTICS, INC.
Model
2000
Catalog number
2000
Device description
Invisiport 4.4 Fr Convenience Kit Contents:Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex);Microaccess Tear-Away Introducer Set;MicroIntroducer needle;Microguidewire;20 Gauge, 1.5 inch, Non-Coring Access Needle
Published
2016-03-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141146000INVISIPORTStealth Therapeutics, Incorporated2015-05-01LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864144000209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864144000209008641440002098641440002090864144000209

GMDN Terms#

Term, Definition table
TermDefinition
Catheter injection portA device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6082172685customerservice@stealththerapeutics.com

Regulatory Flags#

DUNS number
963281709
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15051684018654BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018661BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018678BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018685BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018715BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018722BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018739BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018760BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018791XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018814XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018838XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018883XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018906XcelaAngiodynamics, Inc.LJT2024-09-20
15051684017978Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684017992Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018012Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018036Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018043Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018050Smart Port CTANGIODYNAMICS, INC.LJT2024-07-23
15051684018067Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018111Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018128Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018166Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018173Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018074Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018142Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018180Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018029Smart Port CTAngiodynamics, Inc.LJT2024-06-11
15051684018197Smart Port CTAngiodynamics, Inc.LJT2024-03-13
10801902189612ARROWTELEFLEX INCORPORATEDLJT2022-04-04