gudid
Primary ID: OTP5000
NA (UDI OTP5000)
Manufactured by CAREFUSION 2200, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NA - Primary ID OTP5000
Device Regulatory Overview
The NA (Model/Catalog Number: OTP5000) is a medical device manufactured by CAREFUSION 2200, INC. This product is indexed under FDA Product Code / Category Classification PXI within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OTP5000
- Product Code / EMDN
- PXI
- Device Name
- Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
- Database Sync Date
- 2026-08-09 09:16:32
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 NA?
The registered manufacturer of record for NA is CAREFUSION 2200, INC.
What is the Primary UDI-DI identifier for NA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OTP5000.
What classification code is assigned to this device?
This device is registered under product classification code PXI.
Similar Classification Devices (PXI)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint