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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
Intravenous administration tubing extension set FDA UDI
Device Name
Bi-Extension Set 15 cm (6 in) FDA UDI
Model / Reference
385155 FDA UDI
Description
Bi-Extension Set 15 cm (6 in) FDA UDI

Identifiers

Catalog Number
385155 FDA UDI
Primary DI / UDI-DI
00382903851553 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

Dimensions & Sizes

Size
Length — 6 Inch FDA UDI

Category: Intravenous administration tubing extension set

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

Similar devices

Also classified as Intravenous administration tubing extension set.

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 b32764c3-72cc-4ff6-bc51-d0ee8fbee59b 36 fields · synced Jun 8, 2026