Quick Fill Disposable Syringe Fill Tube

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name: Quick Fill Disposable Syringe Fill Tube FDA UDI
Generic Name: Fluid transfer set, general-purpose FDA UDI
Device Name: Individually Packaged Quick Fill Tubes (QUICK FILL TUBE, MC) (60729288) FDA UDI
Model / Reference: QFT 200 FDA UDI
Description: Individually Packaged Quick Fill Tubes (QUICK FILL TUBE, MC) (60729288) FDA UDI

Identifiers

Catalog Number: QFT 200 FDA UDI
Primary DI / UDI-DI: 00616258005805 FDA UDI
510(k) Number: K800823 FDA UDI
FDA Product Code: DXT FDA UDI
GMDN Term: Fluid transfer set, general-purpose FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 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: Fluid transfer set, general-purpose

Quick Fill Disposable Syringe Fill Tube by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K800823 also covers:

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: Bayer Medical Care Inc.

Sources (1)

FDA UDI 2bbfe591-d080-4585-883e-d3dcd61229c6 36 fields · synced Jun 9, 2026