AccuSert

GUDID 00817708022964

OPTFlow Needle Inserter

EMED TECHNOLOGIES CORPORATION

Injector reset device

• Primary Device ID: 00817708022964
• NIH Device Record Key: 2e78b37c-b114-4e59-a265-6ab85c1edf3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuSert
• Version Model Number: FP-0010033
• Company DUNS: 622637544
• Company Name: EMED TECHNOLOGIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817708022964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213429

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

On-Brand Devices [AccuSert]

• 00817708022988: SAF-SUB-Q Needle Inserter
• 00817708022964: OPTFlow Needle Inserter