gudid
Primary ID: 7770
ABOUND (UDI 7770)
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 ABOUND - Primary ID 7770
Device Regulatory Overview
The ABOUND (Model/Catalog Number: 7770) is a medical device manufactured by ASCENSIA DIABETES CARE US INC.. This product is indexed under FDA Product Code / Category Classification FMK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 7770
- Product Code / EMDN
- FMK
- Device Name
- Welcome kit - contains: CONTOUR NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301939763012), 1 carton of CONTOUR NEXT ONE Blood Glucose Test Strips (Package DI Number 00301937312212), 100 MICROLET lancets (provided sterile), recipe cards, activity cards, resistance bands (labeled latex free), relaxation mask.
- Database Sync Date
- 2026-08-09 09:59:18
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 ABOUND?
The registered manufacturer of record for ABOUND is ASCENSIA DIABETES CARE US INC..
What is the Primary UDI-DI identifier for ABOUND?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7770.
What classification code is assigned to this device?
This device is registered under product classification code FMK.
Similar Classification Devices (FMK)
Other Devices by ASCENSIA DIABETES CARE US INC.
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