Vessel Guardian

FDA UDI

Class II (US FDA UDI)

by Lexion Medical LLC

Identity

Trade Name: VESSEL GUARDIAN FDA UDI
Generic Name: Insufflation gas conditioning tubing set FDA UDI
Device Name: LAPAROSCOPIC VESSEL HARVESTING GAS CONDITIONING DEVICE FDA UDI
Model / Reference: 1117 FDA UDI
Description: LAPAROSCOPIC VESSEL HARVESTING GAS CONDITIONING DEVICE FDA UDI

Identifiers

Catalog Number: 1117 FDA UDI
Primary DI / UDI-DI: 00852588007076 FDA UDI
510(k) Number: K102136 FDA UDI
FDA Product Code: HIF FDA UDI
GMDN Term: Insufflation gas conditioning tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Insufflation gas conditioning tubing set

Vessel Guardian by Lexion Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Lexion Medical LLC

Sources (1)

FDA UDI 61411688-f290-4938-888b-71797a0132f8 35 fields · synced Jun 8, 2026