AMSure Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL (UDI 1)
Manufactured by AMSINO INTERNATIONAL, INC.
Device Regulatory Overview
The AMSure Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL (Model/Catalog Number: 1) is a medical device manufactured by AMSINO INTERNATIONAL, INC.. This product is indexed under FDA Product Code / Category Classification BTT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- BTT
- Device Name
- AMSure Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL
- Database Sync Date
- 2026-08-09 09:59:17
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of AMSure Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL?
The registered manufacturer of record for AMSure Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL is AMSINO INTERNATIONAL, INC..
What is the Primary UDI-DI identifier for AMSure Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.
What classification code is assigned to this device?
This device is registered under product classification code BTT.
Similar Classification Devices (BTT)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint