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Bio-Medicus®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Bio-Medicus® FDA UDI
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
Device Name
CANNULA 98800-108 BIO-MED ART 8F LL CON FDA UDI
Model / Reference
98800-108 FDA UDI
Description
CANNULA 98800-108 BIO-MED ART 8F LL CON FDA UDI

Identifiers

Primary DI / UDI-DI
00613994530585 FDA UDI
510(k) Number
K924642 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 FDA UDI
Commercial Distribution
Not 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 10.0 Centimeter FDA UDI
Catheter Gauge — 8.0 French FDA UDI

Bio-Medicus® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K924642 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 8beeefea-a4a2-41fd-812e-45250f12998a 38 fields · synced May 31, 2026