FDA UDI
In Commercial Distribution
🇺🇸 United States
BIS
DI: 20884521134307
·
Model: 186-0106
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- BIS
- Primary DI
- 20884521134307
- Version / Model
- 186-0106
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-25
- Public Version
- 18
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- b78cb6c8-f274-4616-a48a-10bf3911b5cf
Device Description
4 Electrode Sensor For use with BIS Monitoring Systems
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46620 | Cerebral oximeter sensor, single-use | A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884521133884 | GS1 | CASE | 2 | In Commercial Distribution | |
| Package | 10884521134300 | GS1 | PACK_OR_INNER_PACK | 25 | In Commercial Distribution | |
| Primary | 20884521134307 | GS1 | ||||
| Package | 90884521657508 | GS1 | PALLET | 9999 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 85 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side up; Keep Dry; Fragile