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Micro

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name
MICRO FDA UDI
Generic Name
Cardiopulmonary bypass system filter, arterial blood line FDA UDI
Model / Reference
40 µm Infant Arterial Filter FDA UDI

Identifiers

Primary DI / UDI-DI
08033178114608 FDA UDI
510(k) Number
K242092 FDA UDI
FDA Product Code
DTM FDA UDI
GMDN Term
Cardiopulmonary bypass system filter, arterial blood line FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4260 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Category: Cardiopulmonary bypass system filter, arterial blood line

Micro by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system filter, arterial blood line.

Cleared under the same submission

K242092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sorin Group Italia Srl

Sources (1)

  • FDA UDI d4c44432-5c47-49ae-88d7-6e202db3bfa8 33 fields · synced May 30, 2026