gudid
Primary ID: 900-000-605
Ambu (UDI 900-000-605)
Manufactured by SUNMED, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ambu - Primary ID 900-000-605
Device Regulatory Overview
The Ambu (Model/Catalog Number: 900-000-605) is a medical device manufactured by SUNMED, LLC. This product is indexed under FDA Product Code / Category Classification BZR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 900-000-605
- Product Code / EMDN
- BZR
- Device Name
- Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2 L Bag, 7' O2 and Manometer, Neonatal Mask
- Database Sync Date
- 2026-08-09 09:28:44
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 Ambu?
The registered manufacturer of record for Ambu is SUNMED, LLC.
What is the Primary UDI-DI identifier for Ambu?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 900-000-605.
What classification code is assigned to this device?
This device is registered under product classification code BZR.
Similar Classification Devices (BZR)
Other Devices by SUNMED, LLC
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