Qitexio Luer Lock Syringe 20mL

FDA UDIEUDAMED

Class II (US FDA UDI)

by Medex, Inc.

Identity

Trade Name: Qitexio Luer Lock Syringe 20mL FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Model / Reference: QIT013 FDA UDI

Identifiers

Primary DI / UDI-DI: 23700550400978 FDA UDI
510(k) Number: K203738 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 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

MRI Safety

MR Safe FDA UDI

Category: General-purpose syringe, single-use

Qitexio Luer Lock Syringe 20mL by Medex, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose syringe, single-use.

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SURGYCO — Surgyco LLC · Class I
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

Cleared under the same submission

K203738 also covers:

Qitexio — Medex, Inc.
Qitexio — Medex, Inc.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medex, Inc.

Sources (2)

FDA UDI 7d024780-35e6-45a2-80e2-f382c62db9c2 36 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 4, 2026