gudid
Primary ID: DB+201-2.1
MedicaLyte (UDI DB+201-2.1)
Manufactured by NIPRO RENAL SOLUTIONS USA CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MedicaLyte - Primary ID DB+201-2.1
Device Regulatory Overview
The MedicaLyte (Model/Catalog Number: DB+201-2.1) is a medical device manufactured by NIPRO RENAL SOLUTIONS USA CORPORATION. This product is indexed under FDA Product Code / Category Classification KPO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DB+201-2.1
- Product Code / EMDN
- KPO
- Device Name
- Dry Bicarbonate Powder Concentrate for Hemodialysis
- Database Sync Date
- 2026-08-09 09:31:19
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 MedicaLyte?
The registered manufacturer of record for MedicaLyte is NIPRO RENAL SOLUTIONS USA CORPORATION.
What is the Primary UDI-DI identifier for MedicaLyte?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DB+201-2.1.
What classification code is assigned to this device?
This device is registered under product classification code KPO.
Similar Classification Devices (KPO)
Other Devices by NIPRO RENAL SOLUTIONS USA CORPORATION
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint