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Landmark Catheter Introducer Kit

FDA UDI

Class II (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name
Landmark Catheter Introducer Kit FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
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 The suture and clamp are to be removed immediately after the catheter is withdrawn. FDA UDI
Model / Reference
LR-KIT FDA UDI
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 The suture and clamp are to be removed immediately after the catheter is withdrawn. FDA UDI

Identifiers

Catalog Number
LR-KIT FDA UDI
Primary DI / UDI-DI
B090LRKIT0 FDA UDI
FDA Product Code
OFC FDA UDI
PXB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
880.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Landmark Catheter Introducer Kit by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZIEN Medical Technologies, LLC

Sources (1)

  • FDA UDI 135cb109-ae77-442c-a926-d824a264ec49 34 fields · synced Jun 1, 2026