OPTFlow

Basic Information

• Brand Name: OPTFlow
• Primary DI: 10817708021995
• Version / Model: OPT12609-Q10
• Catalog Number: OPT12609-Q10
• Company Name: EMED TECHNOLOGIES CORPORATION
• Labeler DUNS: 622637544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-12-07
• Public Version: 1
• Public Version Date: 2020-12-15
• Public Version Status: New
• Public Device Record Key: 81711cd5-7adb-4e4c-9cba-90663a59c8d5

Device Description

OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 70cm Tubing with safety mechanism, Box of 10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46846	Mechanical infusion pump administration set	A collection of sterile devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00817708021998	GS1
Primary	10817708021995	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140131	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 Needle
Needle Gauge	26	Gauge
Length	9	Millimeter
Length	70	Centimeter
Total Volume	0.28	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius