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Quantum PureFlow Standard Heat Exchanger High Flow 3/8

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 FDA UDI
Generic Name
Cardiopulmonary bypass system heat exchanger, single-use FDA UDI
Model / Reference
HX55W-S0 FDA UDI

Identifiers

Primary DI / UDI-DI
08051160301171 FDA UDI
510(k) Number
K212688 FDA UDI
K220110 FDA UDI
K223879 FDA UDI
FDA Product Code
DTR FDA UDI
GMDN Term
Cardiopulmonary bypass system heat exchanger, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4240 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger High Flow 3/8 by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system heat exchanger, single-use.

Cleared under the same submission

K212688 also covers:

K220110 also covers:

K223879 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Medical Limited

Sources (1)

  • FDA UDI 35e3bd16-800a-4465-9517-71b5ba750a45 33 fields · synced Jun 8, 2026