High-Flo Subcutaneous Safety Needle Sets (UDI 00659443004580)
Manufactured by KORU Medical Systems, Inc
Device Regulatory Overview
The High-Flo Subcutaneous Safety Needle Sets (Model/Catalog Number: 11851-325-07) is a medical device manufactured by KORU Medical Systems, Inc. This product is indexed under FDA Product Code / Category Classification A010199 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 11851-325-07
- Product Code / EMDN
- A010199
- Device Name
- High-Flo Subcutaneous Safety Needle Sets
- Database Sync Date
- 2026-08-09 16:29:47
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of High-Flo Subcutaneous Safety Needle Sets?
The registered manufacturer of record for High-Flo Subcutaneous Safety Needle Sets is KORU Medical Systems, Inc.
What is the Primary UDI-DI identifier for High-Flo Subcutaneous Safety Needle Sets?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00659443004580.
What classification code is assigned to this device?
This device is registered under product classification code A010199.
Similar Classification Devices (A010199)
Other Devices by KORU Medical Systems, Inc
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