AU (UDI OSR6637)
Manufactured by Beckman Coulter, Inc.
Device Regulatory Overview
The AU (Model/Catalog Number: OSR6637) is a medical device manufactured by Beckman Coulter, Inc.. This product is indexed under FDA Product Code / Category Classification KHS 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
- OSR6637
- Product Code / EMDN
- KHS
- Device Name
- Bicarbonate
- Database Sync Date
- 2026-08-09 09:22:51
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 AU?
The registered manufacturer of record for AU is Beckman Coulter, Inc..
What is the Primary UDI-DI identifier for AU?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OSR6637.
What classification code is assigned to this device?
This device is registered under product classification code KHS.
Similar Classification Devices (KHS)
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