FDA.reportPublic FDA data

T-Port

Primary DI
76401109884356
Brand
T-Port
Company
PFM MEDICAL INCORPORATED
Model
616.366.2087-HA
Catalog number
616.366.2087-HA
Device description
T-PORT LP HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter
Published
2016-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
K073210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073210000MODIFICATION TO: T-PORT HP INFUSION PORTPfm Medical, Inc.2007-12-12LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
76401109884356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7640110988435676401109884356

GMDN Terms#

Term, Definition table
TermDefinition
Infusion/injection port, implantableA sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607588749customerservice@pfmmedicalusa.

Regulatory Flags#

DUNS number
097736867
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
00813623011144ASEPT Peritoneal Drainage System6222796222792016-10-01
00813623015371ASEPT Peritoneal Drainage SystemM7000M70002015-10-15
00813623017016ASEPT Pleural Drainage SystemM7001M70012016-10-02
00813623012066ASEPTM7050M70502016-10-05
00813623017054ASEPTM7005M70052019-03-31
00813623040878Jet-VacM7098M70982019-03-31
00813623040885Jet-VacM7097M70972019-03-31
00813623011267BBraun Multi-Snare6129706129702016-09-29
00813623011274BBraun Multi-Snare6129716129712016-09-29
00813623011281BBraun Multi-Snare6129726129722016-09-29
00813623011298BBraun Multi-Snare6129736129732016-09-29
00813623011304BBraun Multi-Snare6129746129742016-09-29
00813623011311BBraun Multi-Snare6129756129752016-09-29
00813623011328BBraun Multi-Snare6129766129762016-09-29
00813623010352Tita Jet616.368.3077-HAV616.368.3077-HAV2021-05-31
00813623010369Tita Jet616.368.2087-HAV616.368.2087-HAV2021-05-31
00813623010376Jet Port616.367.3077-HAV616.367.3077-HAV2021-05-31
00813623010383Jet Port616.367.2087-HAV616.367.2087-HAV2021-05-31
00813623010390Jet Port616.021.0078-HAV616.021.0078-HAV2021-05-31
00813623010406Tita Jet616.022.0078-HAV616.022.0078-HAV2021-05-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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