Ultraflo-R

FDA UDI

Class II (US FDA UDI)

by Innovative Medical Technologies, Inc.

Identity

Trade Name: ULTRAFLO-R FDA UDI
Generic Name: Blood collection set, invasive FDA UDI
Device Name: PUSH BUTTON SAFETY BLOOD COLLECTION AND INFUSION SET 23GX3/4"X12" W/O LUER ADAPTER FDA UDI
Model / Reference: 324 FDA UDI
Description: PUSH BUTTON SAFETY BLOOD COLLECTION AND INFUSION SET 23GX3/4"X12" W/O LUER ADAPTER FDA UDI

Identifiers

Catalog Number: 324 FDA UDI
Primary DI / UDI-DI: 10857182006583 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: Blood collection set, invasive 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

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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Blood collection set, invasive Basic intravenous administration set, invasive

Ultraflo-R by Innovative Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, invasive.

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SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
SURFLO™ — Terumo Europe NV · Class II
VACUETTE — Greiner Bio-One GmbH · Class II
SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II

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: Innovative Medical Technologies, Inc.

Sources (1)

FDA UDI 4d6a5ecb-491c-46ec-a982-19549721c43d 35 fields · synced Jun 8, 2026