Delivery Set 16C w/ AA 183cm Line

FDA UDI

Class II (US FDA UDI)

by Quest Medical Inc

Identity

Trade Name: Delivery Set 16C w/ AA 183cm Line FDA UDI
Generic Name: Cardioplegia solution administration kit FDA UDI
Model / Reference: 5161102-AS FDA UDI

Identifiers

Primary DI / UDI-DI: 00634624561144 FDA UDI
510(k) Number: K173716 FDA UDI
FDA Product Code: DTR FDA UDI
GMDN Term: Cardioplegia solution administration kit 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardioplegia solution administration kit

Delivery Set 16C w/ AA 183cm Line by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardioplegia solution administration kit.

Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
MyOtherm XP® — MEDTRONIC, INC. · Class II
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class I
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class I
Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II

Cleared under the same submission

K173716 also covers:

MPS Water Circuit Adapter, 16C — QUEST MEDICAL INC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Quest Medical Inc

Sources (1)

FDA UDI fcc1ecc2-c918-4a30-8edf-299c686d06ee 33 fields · synced May 30, 2026