Identity
- Trade Name
- BIS FDA UDI
- Generic Name
- Anaesthesia depth monitor FDA UDI
- Device Name
- BISX Module,Refurbished, Software Version 1.13,For Mindray Monitors FDA UDI
- Model / Reference
- 186-0199-DS FDA UDI
- Description
- BISX Module,Refurbished, Software Version 1.13,For Mindray Monitors FDA UDI
Identifiers
- Catalog Number
- 186-0199-DS FDA UDI
- Primary DI / UDI-DI
- 10884521130296 FDA UDI
- 510(k) Number
- K072286 FDA UDI
- FDA Product Code
- OLW FDA UDI
- GMDN Term
- Anaesthesia depth monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bis by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K072286 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 4b4fbfe0-d960-4011-b7e7-0d4e663937fd 38 fields · synced Jun 1, 2026