SafeFill

FDA UDI

Class II (US FDA UDI)

by Q.I. Medical, Inc.

Identity

Trade Name: SafeFill FDA UDI
Generic Name: Fluid transfer set, general-purpose FDA UDI
Device Name: Large Vial Adapter, 1 each, female luer slip outlet, locking flanges FDA UDI
Model / Reference: Large Vial Adapter FDA UDI
Description: Large Vial Adapter, 1 each, female luer slip outlet, locking flanges FDA UDI

Identifiers

Catalog Number: SF200L FDA UDI
Primary DI / UDI-DI: 00854989006023 FDA UDI
510(k) Number: K921031 FDA UDI
FDA Product Code: LHI FDA UDI
GMDN Term: Fluid transfer set, general-purpose 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Fluid transfer set, general-purpose

SafeFill by Q.I. Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K921031 also covers:

SafeFill — Q.I. Medical, Inc.
SafeFill — Q.I. Medical, Inc.

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: Q.I. Medical, Inc.

Sources (1)

FDA UDI fdb23d34-8052-4ddb-9483-95ae84d7e6e7 35 fields · synced May 30, 2026