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Q-Syte

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
Q-Syte FDA UDI
Generic Name
Negative-pressure intravenous line needleless valve-connector FDA UDI
Device Name
Luer Access Split Septum FDA UDI
Model / Reference
385103 FDA UDI
Description
Luer Access Split Septum FDA UDI

Identifiers

Catalog Number
385103 FDA UDI
Primary DI / UDI-DI
00382903851034 FDA UDI
510(k) Number
K013621 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Negative-pressure intravenous line needleless valve-connector 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

Dimensions & Sizes

Size
Length — 6 Inch FDA UDI

Category: Negative-pressure intravenous line needleless valve-connector

Q-Syte by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure intravenous line needleless valve-connector.

Cleared under the same submission

K013621 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI 1e4fda51-c6e7-4a27-9cb8-b5a18db17759 38 fields · synced May 30, 2026