OPTFlow

FDA UDI

Class II (US FDA UDI)

by EMED Technologies Corporation

Identity

Trade Name: OPTFlow FDA UDI
Generic Name: Mechanical infusion pump administration set FDA UDI
Device Name: OPTFlow SUB-Q 3 Needle set, 24ga TW x 9mm, 70cm Tubing with safety mechanism FDA UDI
Model / Reference: OPT32409U FDA UDI
Description: OPTFlow SUB-Q 3 Needle set, 24ga TW x 9mm, 70cm Tubing with safety mechanism FDA UDI

Identifiers

Catalog Number: OPT32409U FDA UDI
Primary DI / UDI-DI: 00817708022643 FDA UDI
510(k) Number: K140131 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: Mechanical infusion pump administration 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

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

Dimensions & Sizes

Size: Needle Gauge — 24 Gauge FDA UDI
Length — 9 Millimeter FDA UDI
Length — 70 Centimeter FDA UDI
Total Volume — 1.2 Milliliter FDA UDI

Category: Mechanical infusion pump administration set

OPTFlow by EMED Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical infusion pump administration set.

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Primrose Medical, Inc — PRIMROSE MEDICAL, INC. · Class II
RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC. · Class II
Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
AVID TruCustom — AVID MEDICAL, INC. · Class II

Cleared under the same submission

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: EMED Technologies Corporation

Sources (1)

FDA UDI 6503f606-47a1-4c2a-bb01-13d5f6aaf9dd 38 fields · synced Jun 9, 2026