VentStar Helix heated

FDA UDI

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: VentStar Helix heated FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Model / Reference: MP02607 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675253372 FDA UDI
510(k) Number: K102618 FDA UDI
FDA Product Code: BTT FDA UDI
GMDN Term: Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5450 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

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

MRI Safety

MR Unsafe FDA UDI

Category: Ventilator breathing circuit, single-use

VentStar Helix heated by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K102618 also covers:

VentStar Helix dual heated — Drägerwerk AG & Co. KGaA

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: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI a4eb7f5c-1d94-4473-a05e-3ebd863c529c 34 fields · synced Jun 1, 2026