gudid
Primary ID: HEMVTOM1
HemoSphere Vita (UDI HEMVTOM1)
Manufactured by Edwards Lifesciences LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HemoSphere Vita - Primary ID HEMVTOM1
Device Regulatory Overview
The HemoSphere Vita (Model/Catalog Number: HEMVTOM1) is a medical device manufactured by Edwards Lifesciences LLC. This product is indexed under FDA Product Code / Category Classification DXN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HEMVTOM1
- Product Code / EMDN
- DXN
- Device Name
- Vita Technology Module
- Database Sync Date
- 2026-08-09 09:04:21
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 HemoSphere Vita?
The registered manufacturer of record for HemoSphere Vita is Edwards Lifesciences LLC.
What is the Primary UDI-DI identifier for HemoSphere Vita?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HEMVTOM1.
What classification code is assigned to this device?
This device is registered under product classification code DXN.
Similar Classification Devices (DXN)
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