eudamed_udi
Primary ID: 04250476606954
PRIME|ONE COOL BREATH (UDI 04250476606954)
Manufactured by Akzenta International SA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PRIME|ONE COOL BREATH - Primary ID 04250476606954
Device Regulatory Overview
The PRIME|ONE COOL BREATH (Model/Catalog Number: FAMDA24-AKZ-FU-K00) is a medical device manufactured by Akzenta International SA. This product is indexed under FDA Product Code / Category Classification T020604 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FAMDA24-AKZ-FU-K00
- Product Code / EMDN
- T020604
- Device Name
- FACE MASKS
- Database Sync Date
- 2026-08-09 16:29:04
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 PRIME|ONE COOL BREATH?
The registered manufacturer of record for PRIME|ONE COOL BREATH is Akzenta International SA.
What is the Primary UDI-DI identifier for PRIME|ONE COOL BREATH?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04250476606954.
What classification code is assigned to this device?
This device is registered under product classification code T020604.
Similar Classification Devices (T020604)
Other Devices by Akzenta International SA
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