FDA.report

Lifeport

Primary DI
H787LPS50130
Brand
Lifeport
Company
NAVILYST MEDICAL, INC.
Model
LPS5013
Device description
Lifeport Single Titanium Port System with Attachable 9.6F x 76cm Silicone Catheter
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K905839000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K905839000STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIEDStrato Medical Corp.1991-04-19LJT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H787LPS50130PrimaryHIBCC0
15051684018203SecondaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Catheter Gauge9.6French
Length76Centimeter
Lumen/Inner Diameter1.5Millimeter
Needle Gauge18Gauge
Outer Diameter3.2Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags

DUNS number
809699023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29
H787CT50LPBDNFVI0BioFlo VortexCT50LPBDNFVI2020-05-29
H787CT50LPBDVI0BioFlo VortexCT50LPBDVI2020-05-29
H787CT50LTBANFVI0BioFlo VortexCT50LTBANFVI2020-05-29
H787CT50LTBAVI0BioFlo VortexCT50LTBAVI2020-05-29
H787CT50LTBDNFVI0BioFlo VortexCT50LTBDNFVI2020-05-29
H787CT50LTBDVI0BioFlo VortexCT50LTBDVI2020-05-29
H787CT50PTBANFVI0BioFlo VortexCT50PTBANFVI2020-05-29
H787CT50PTBAVI0BioFlo VortexCT50PTBAVI2020-05-29
H787CT50PTBDNFVI0BioFlo VortexCT50PTBDNFVI2020-05-29
H787CT50PTBDVI0BioFlo VortexCT50PTBDVI2020-05-29
H787CT50STBDNFVI0BioFlo VortexCT50STBDNFVI2020-05-29
H787CT50STBDVI0BioFlo VortexCT50STBDVI2020-05-29
H787CT60LPBANFVI0BioFlo VortexCT60LPBANFVI2020-05-29
H787CT60LPBAVI0BioFlo VortexCT60LPBAVI2020-05-29
H787CT60LPBDNFVI0BioFlo VortexCT60LPBDNFVI2020-05-29
H787CT60LPBDVI0BioFlo VortexCT60LPBDVI2020-05-29
H787CT60LPPANFNV0BioFlo VortexCT60LPPANFNV2020-05-29
H787CT60LPPANFVI0BioFlo VortexCT60LPPANFVI2020-05-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
30801741232429AllPoints Port Access System PowerLocBard Access Systems, Inc.LJT2024-12-05
15051684016858BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684016865BioFlo VortexAngiodynamics, Inc.LJT2024-11-19
15051684018692BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018708BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018746BioFloAngiodynamics, Inc.LJT2024-09-20
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
15051684018104Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018135Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018159Smart Port CTAngiodynamics, Inc.LJT2024-07-23
50884908179403DIGNITY®Medical Components, Inc.LJT2024-04-25