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Affinity Pixie™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Affinity Pixie™ FDA UDI
Generic Name
Cardiopulmonary bypass system filter, arterial blood line FDA UDI
Device Name
ARTERIAL FILTER BB4014PEDS BB STERILE FDA UDI
Model / Reference
BB4014 FDA UDI
Description
ARTERIAL FILTER BB4014PEDS BB STERILE FDA UDI

Identifiers

Primary DI / UDI-DI
00613994617323 FDA UDI
510(k) Number
K100646 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary bypass system filter, arterial blood line

Affinity Pixie™ by Medtronic, Inc. — 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

K100646 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI c79e9b1b-c7f4-4fa4-a2f5-ee1fc372aa6f 36 fields · synced Jun 8, 2026