gudid
Primary ID: 1491A
BREEZE 2 (UDI 1491A)
Manufactured by ASCENSIA DIABETES CARE US INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BREEZE 2 - Primary ID 1491A
Device Regulatory Overview
The BREEZE 2 (Model/Catalog Number: 1491A) is a medical device manufactured by ASCENSIA DIABETES CARE US INC.. This product is indexed under FDA Product Code / Category Classification JJX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1491A
- Product Code / EMDN
- JJX
- Device Name
- Control Solution - High, 1 x 2.5 mL
- Database Sync Date
- 2026-08-09 09:34:07
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 BREEZE 2?
The registered manufacturer of record for BREEZE 2 is ASCENSIA DIABETES CARE US INC..
What is the Primary UDI-DI identifier for BREEZE 2?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1491A.
What classification code is assigned to this device?
This device is registered under product classification code JJX.
Similar Classification Devices (JJX)
Other Devices by ASCENSIA DIABETES CARE US INC.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint