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HLS Set

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name
HLS Set FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
HIT Set Advanced 7.0, Adult, SOFTLINE Coating FDA UDI
Model / Reference
BO-HLS 7050 USA FDA UDI
Description
HIT Set Advanced 7.0, Adult, SOFTLINE Coating FDA UDI

Identifiers

Catalog Number
701069081 FDA UDI
Primary DI / UDI-DI
04058863078861 FDA UDI
510(k) Number
K112360 FDA UDI
FDA Product Code
DTZ FDA UDI
DTR FDA UDI
KFM FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4350 FDA UDI
870.4240 FDA UDI
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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 600 Milliliter FDA UDI

Category: Cardiopulmonary bypass system blood tubing set

HLS Set by Maquet Cardiopulmonary AG — 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

K112360 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (1)

  • FDA UDI 465d67f7-c6f8-463d-a1e8-c0a33e509b31 36 fields · synced May 31, 2026