Vapor 2000

FDA UDIEUDAMED

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: Vapor 2000 FDA UDI
Generic Name: Halothane anaesthesia vaporizer FDA UDI
Model / Reference: M35054 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675228059 FDA UDI
510(k) Number: K971923 FDA UDI
FDA Product Code: CAD FDA UDI
GMDN Term: Halothane anaesthesia vaporizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Halothane anaesthesia vaporizer

Vapor 2000 by Drägerwerk AG & Co. KGaA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Cleared under the same submission

K971923 also covers:

Vapor 3000 — Drägerwerk AG & Co. KGaA

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Drägerwerk AG & Co. KGaA

Sources (2)

FDA UDI 0c1bad5a-f7fd-45df-8db4-3b5321749978 34 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026