gudid
Primary ID: ESC-40
EsoCool (UDI ESC-40)
Manufactured by Nuvaira, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EsoCool - Primary ID ESC-40
Device Regulatory Overview
The EsoCool (Model/Catalog Number: ESC-40) is a medical device manufactured by Nuvaira, Inc.. This product is indexed under FDA Product Code / Category Classification KMJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ESC-40
- Product Code / EMDN
- KMJ
- Device Name
- EsoCool Esophageal Cooling Catheter, 40 cm
- Database Sync Date
- 2026-08-09 09:37:41
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 EsoCool?
The registered manufacturer of record for EsoCool is Nuvaira, Inc..
What is the Primary UDI-DI identifier for EsoCool?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ESC-40.
What classification code is assigned to this device?
This device is registered under product classification code KMJ.
Similar Classification Devices (KMJ)
Other Devices by Nuvaira, Inc.
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