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Q2 Low Pressure Power Injection Extension Set

FDA UDI

Class II (US FDA UDI)

by Quest Medical Inc

Identity

Trade Name
Q2 Low Pressure Power Injection Extension Set FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
7 inch IV extension set FDA UDI
Model / Reference
95714 FDA UDI
Description
7 inch IV extension set FDA UDI

Identifiers

Catalog Number
95714 FDA UDI
Primary DI / UDI-DI
00634624957145 FDA UDI
510(k) Number
K162804 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Intravenous administration tubing extension set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

Category: Intravenous administration tubing extension set

Q2 Low Pressure Power Injection Extension Set by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Cleared under the same submission

K162804 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quest Medical Inc

Sources (1)

  • FDA UDI f390bfbe-2ad5-456d-98d9-5ea9a0d5ce2b 36 fields · synced May 31, 2026