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Dlp®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
DLP® FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
SET 61000 PRESSURE DISPLAY 45 10PK 17L FDA UDI
Model / Reference
61000 FDA UDI
Description
SET 61000 PRESSURE DISPLAY 45 10PK 17L FDA UDI

Identifiers

Primary DI / UDI-DI
20613994846604 FDA UDI
510(k) Number
K852232 FDA UDI
FDA Product Code
DXS FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4310 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

Dimensions & Sizes

Size
Length — 114.3 Centimeter FDA UDI

Category: Cardiopulmonary bypass system blood tubing set

Dlp® 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

K852232 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 c4e87ea6-bfc1-4e18-81b2-ccf05bba4750 36 fields · synced May 30, 2026