BIS (UDI 186-0106-PH)
Manufactured by Covidien LP
Device Regulatory Overview
The BIS (Model/Catalog Number: 186-0106-PH) is a medical device manufactured by Covidien LP. This product is indexed under FDA Product Code / Category Classification OLW 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
- 186-0106-PH
- Product Code / EMDN
- OLW
- Device Name
- Quatro Sensor Kit, (25) 186-0106
- Database Sync Date
- 2026-08-09 09:16:45
Full Regulatory Attributes
🔒 Token Gated
{
"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 BIS?
The registered manufacturer of record for BIS is Covidien LP.
What is the Primary UDI-DI identifier for BIS?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 186-0106-PH.
What classification code is assigned to this device?
This device is registered under product classification code OLW.
Similar Classification Devices (OLW)
Other Devices by Covidien LP
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