Bibag (UDI 08-4080-BB)
Manufactured by Fresenius Medical Care Holdings, Inc.
Device Regulatory Overview
The Bibag (Model/Catalog Number: 08-4080-BB) is a medical device manufactured by Fresenius Medical Care Holdings, Inc.. This product is indexed under FDA Product Code / Category Classification KPO within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 08-4080-BB
- Product Code / EMDN
- KPO
- Device Name
- Bibag Dry Sodium Bicarbonate
- Database Sync Date
- 2026-08-09 09:35:09
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 Bibag?
The registered manufacturer of record for Bibag is Fresenius Medical Care Holdings, Inc..
What is the Primary UDI-DI identifier for Bibag?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08-4080-BB.
What classification code is assigned to this device?
This device is registered under product classification code KPO.
Similar Classification Devices (KPO)
Other Devices by Fresenius Medical Care Holdings, Inc.
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