Silicone Breathing Bag, 1L w/Loop End (UDI 06923980112362)
Manufactured by GaleMed (Xiamen) Co., Ltd.
Device Regulatory Overview
The Silicone Breathing Bag, 1L w/Loop End (Model/Catalog Number: AB0108) is a medical device manufactured by GaleMed (Xiamen) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification R028099 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- AB0108
- Product Code / EMDN
- R028099
- Device Name
- Disposable Breathing bag
- Database Sync Date
- 2026-08-09 16:29:50
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 Silicone Breathing Bag, 1L w/Loop End?
The registered manufacturer of record for Silicone Breathing Bag, 1L w/Loop End is GaleMed (Xiamen) Co., Ltd..
What is the Primary UDI-DI identifier for Silicone Breathing Bag, 1L w/Loop End?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06923980112362.
What classification code is assigned to this device?
This device is registered under product classification code R028099.
Similar Classification Devices (R028099)
Other Devices by GaleMed (Xiamen) Co., Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint