CATHTONG II

GUDID 00861744000134

5F Dual Lumen PICC Kit

L & Z Us, Inc.

Peripherally-inserted central venous catheter
Primary Device ID00861744000134
NIH Device Record Keyb398430e-c1b2-4aca-b6f4-a723e67c9332
Commercial Distribution StatusIn Commercial Distribution
Brand NameCATHTONG II
Version Model Number5252111
Company DUNS038492590
Company NameL & Z Us, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com
Phone+1(201)660-8868
Emailinfo@lingzeus.com

Device Dimensions

Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter
Catheter Gauge5 French
Length55 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005381037 [Package]
Package: CASE [10 Units]
In Commercial Distribution
GS100850005381518 [Package]
Package: CASE [10 Units]
In Commercial Distribution
GS100861744000134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [CATHTONG II]

008617440001584F Single Lumen PICC Kit
008617440001345F Dual Lumen PICC Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.