FDA.reportPublic FDA data

Landmark Catheter Introducer Kit

Primary DI
B090LRKIT0
Brand
Landmark Catheter Introducer Kit
Company
Zien Medical Technologies, LLC
Model
LR-KIT
Catalog number
LR-KIT
Device description
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 The suture and clamp are to be removed immediately after the catheter is withdrawn.
Published
2024-04-24
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
OFCCatheter Introducer Kit
PXBPercutaneous Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFCCatheter Introducer KitCardiovascular2
PXBPercutaneous Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090LRKIT1PackageHIBCC5In Commercial Distribution
B090LRKIT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Regulatory Flags#

DUNS number
017535668
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
true
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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850001105125Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2024-10-16
B090LRKIT1Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
10197106407257CARDINAL HEALTHCardinal Health 200, LLCPXB2023-08-11
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10197106114018CARDINAL HEALTHCardinal Health 200, LLCPXB2023-02-07
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00863092000101Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2022-12-15
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50888439783825CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
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