Monoject (UDI 405E)
Manufactured by Cardinal Health 200, LLC
Device Regulatory Overview
The Monoject (Model/Catalog Number: 405E) is a medical device manufactured by Cardinal Health 200, LLC. This product is indexed under FDA Product Code / Category Classification PNR within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 405E
- Product Code / EMDN
- PNR
- Device Name
- ENFit 0.5 ml Syringe Non-Sterile
- Database Sync Date
- 2026-08-09 09:16:54
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 Monoject?
The registered manufacturer of record for Monoject is Cardinal Health 200, LLC.
What is the Primary UDI-DI identifier for Monoject?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 405E.
What classification code is assigned to this device?
This device is registered under product classification code PNR.
Similar Classification Devices (PNR)
Other Devices by Cardinal Health 200, LLC
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