gudid
Primary ID: ABI-450CL
simpleABI (UDI ABI-450CL)
Manufactured by NEWMAN MEDICAL LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for simpleABI - Primary ID ABI-450CL
Device Regulatory Overview
The simpleABI (Model/Catalog Number: ABI-450CL) is a medical device manufactured by NEWMAN MEDICAL LLC. This product is indexed under FDA Product Code / Category Classification JAF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ABI-450CL
- Product Code / EMDN
- JAF
- Device Name
- ABI-450CL Software, 4 port Cuff-Link with remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 2x12cm cuffs, 2x2.5cm disposable digit cuffs, roll stand, user manual, quick reference guides.
- Database Sync Date
- 2026-08-09 09:49:32
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 simpleABI?
The registered manufacturer of record for simpleABI is NEWMAN MEDICAL LLC.
What is the Primary UDI-DI identifier for simpleABI?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ABI-450CL.
What classification code is assigned to this device?
This device is registered under product classification code JAF.
Similar Classification Devices (JAF)
Other Devices by NEWMAN MEDICAL LLC
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