Ventlab

FDA UDI

Class II (US FDA UDI)

by Ventlab Corp.

Identity

Trade Name: Ventlab FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: Small Cannula System w/ Soft Headgear & Circuit FDA UDI
Model / Reference: CS4000CS FDA UDI
Description: Small Cannula System w/ Soft Headgear & Circuit FDA UDI

Identifiers

Primary DI / UDI-DI: 10889483105498 FDA UDI
510(k) Number: K040726 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Category: Anaesthesia breathing circuit, single-use

Ventlab by Ventlab Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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UNIVERSAL FLEX2® — KING SYSTEMS CORPORATION. · Class I
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Cleared under the same submission

K040726 also covers:

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: Ventlab Corp.

Sources (1)

FDA UDI 84d408bf-5c29-4150-8229-761efb2fffed 36 fields · synced May 30, 2026