FDA.report

Lifeport

Primary DI
H787LPS70150
Brand
Lifeport
Company
NAVILYST MEDICAL, INC.
Model
LPS7015
Device description
Lifeport Single Plastic Port System with Attached 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
K911355000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K911355000LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015Strato Medical Corp.1991-04-15LJT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H787LPS70150PrimaryHIBCC0
15051684018234SecondaryGS10

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

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