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Custom Perfusion System

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Custom Perfusion System FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
CUSTOM PACK TL0E27R26 ST FRNCS FDA UDI
Model / Reference
TL0E27R26 FDA UDI
Description
CUSTOM PACK TL0E27R26 ST FRNCS FDA UDI

Identifiers

Primary DI / UDI-DI
00643169639188 FDA UDI
510(k) Number
K973011 FDA UDI
FDA Product Code
KFM FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4360 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

Custom Perfusion System 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

K973011 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 4e786b0a-1c74-4bad-a074-b1aaa46490ed 36 fields · synced May 31, 2026