gudid
Primary ID: FGS-0541
RAPID (UDI FGS-0541)
Manufactured by Given Imaging, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for RAPID - Primary ID FGS-0541
Device Regulatory Overview
The RAPID (Model/Catalog Number: FGS-0541) is a medical device manufactured by Given Imaging, Inc.. This product is indexed under FDA Product Code / Category Classification NEZ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FGS-0541
- Product Code / EMDN
- NEZ
- Device Name
- SW upgrade, v8.0 US
- Database Sync Date
- 2026-08-09 09:18:16
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of RAPID?
The registered manufacturer of record for RAPID is Given Imaging, Inc..
What is the Primary UDI-DI identifier for RAPID?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FGS-0541.
What classification code is assigned to this device?
This device is registered under product classification code NEZ.
Similar Classification Devices (NEZ)
Other Devices by Given Imaging, Inc.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint