FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIS
DI: 10884521130296
·
Model: 186-0199-DS
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIS
- Primary DI
- 10884521130296
- Version / Model
- 186-0199-DS
- Catalog Number
- 186-0199-DS
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 4
- Public Version Date
- 2023-01-04
- Public Version Status
- Update
- Public Device Record Key
- 4b4fbfe0-d960-4011-b7e7-0d4e663937fd
- Distribution End Date
- 2020-03-04
Device Description
BISX Module,Refurbished, Software Version 1.13,For Mindray Monitors
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLW | Index-generating electroencephalograph software | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41920 | Anaesthesia depth monitor | A mains electricity (AC-powered) device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. It is based upon the bispectral index (BIS) analysis of the electroencephalogram waveform and other features of this, enabling detection of, e.g., levels of sedation, loss of consciousness, and recall. It is used during anaesthesia administration and in trauma. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521130296 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072286 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 47.9961 – 106.6579 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 12 – 107 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side UP;Keep Dry;Fragile;