← Back to catalogue

Filter/HME TwinStar 10A

FDA UDI

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name
Filter/HME TwinStar 10A FDA UDI
Generic Name
Heat/moisture exchanger/microbial medical gas filter FDA UDI
Model / Reference
MP01825 FDA UDI

Identifiers

Primary DI / UDI-DI
04048675041344 FDA UDI
510(k) Number
K072002 FDA UDI
FDA Product Code
CAH FDA UDI
GMDN Term
Heat/moisture exchanger/microbial medical gas filter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5260 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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
MRI Safety
MR Unsafe FDA UDI

Filter/HME TwinStar 10A by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K072002 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Drägerwerk AG & Co. KGaA

Sources (1)

  • FDA UDI 16324615-1553-4be4-8ea7-7db77308e763 35 fields · synced May 31, 2026