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Intersept™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Intersept™ FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
CON CB4613 INTSPT BIACT1/2X1/2X1/2Y 10PK FDA UDI
Model / Reference
CB4613 FDA UDI
Description
CON CB4613 INTSPT BIACT1/2X1/2X1/2Y 10PK FDA UDI

Identifiers

Primary DI / UDI-DI
00643169767089 FDA UDI
510(k) Number
K891687 FDA UDI
FDA Product Code
DTZ FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4350 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

Yes

FDA UDI

Combination Product

Yes

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 blood tubing set

Intersept™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system blood tubing set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI dbcf43f0-a822-485f-8b2c-9801bb77db3e 37 fields · synced Jun 6, 2026