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Pentair

FDA UDI

Class II (US FDA UDI)

by Pentair Filtration Solutions

Identity

Trade Name
Pentair FDA UDI
Generic Name
Cardiopulmonary bypass system filter, priming solution FDA UDI
Model / Reference
0008002023 FDA UDI

Identifiers

Catalog Number
DPC2023S500C FDA UDI
Primary DI / UDI-DI
B46200080020235 FDA UDI
510(k) Number
K982385 FDA UDI
FDA Product Code
KRJ FDA UDI
GMDN Term
Cardiopulmonary bypass system filter, priming solution FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4280 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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 filter, priming solution

Pentair by Pentair Filtration Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system filter, priming solution.

Cleared under the same submission

K982385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pentair Filtration Solutions

Sources (1)

  • FDA UDI 2bd64f83-fd5b-4aa6-a64a-295c265e53f8 36 fields · synced May 29, 2026