Landmark Catheter Introducer Kit LR-KIT

GUDID B090LRKIT1

The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended for temporary securement of the catheter clamp to the patient’s skin. The suture and clamp are to be removed immediately after the catheter is withdrawn.

ZIEN MEDICAL TECHNOLOGIES, INC.

Vascular catheter introduction set, nonimplantable
Primary Device IDB090LRKIT1
NIH Device Record Key135cb109-ae77-442c-a926-d824a264ec49
Commercial Distribution StatusIn Commercial Distribution
Brand NameLandmark Catheter Introducer Kit
Version Model NumberLR-KIT
Catalog NumberLR-KIT
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090LRKIT0 [Primary]
HIBCCB090LRKIT1 [Package]
Contains: B090LRKIT0
Package: Shipper [5 Units]
In Commercial Distribution

FDA Product Code

OFCCatheter Introducer Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-02
Device Publish Date2024-04-24

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