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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
CONN 6006 1/4 Y/LL FDA UDI
Model / Reference
6006 FDA UDI
Description
CONN 6006 1/4 Y/LL FDA UDI

Identifiers

Primary DI / UDI-DI
00673978554884 FDA UDI
510(k) Number
K800178 FDA UDI
FDA Product Code
DWE FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4390 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

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

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.

Cleared under the same submission

K800178 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 b40c2ea2-0453-4715-a1ca-b1d14c2fec0b 36 fields · synced Jun 8, 2026