eudamed_udi
Primary ID: 00704411018943
AMSure® Sterile Water (UDI 00704411018943)
Manufactured by Amsino International Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AMSure® Sterile Water - Primary ID 00704411018943
Device Regulatory Overview
The AMSure® Sterile Water (Model/Catalog Number: AS399K) is a medical device manufactured by Amsino International Inc.. This product is indexed under FDA Product Code / Category Classification M04040101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- AS399K
- Product Code / EMDN
- M04040101
- Device Name
- Sterile Water, and Sterile Normal Saline for Wound Flush
- Database Sync Date
- 2026-08-09 18:12:13
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 AMSure® Sterile Water?
The registered manufacturer of record for AMSure® Sterile Water is Amsino International Inc..
What is the Primary UDI-DI identifier for AMSure® Sterile Water?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00704411018943.
What classification code is assigned to this device?
This device is registered under product classification code M04040101.
Similar Classification Devices (M04040101)
Other Devices by Amsino International Inc.
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