BIS
BIS (TM) Advance Adapter Cable;Also for use with HealthCast (TM) insight patient monitor PM5000;Reusable cable
4manufacturers in China registered for this device type
57catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | OLW |
| Device type | Index-Generating Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| 510(k) | K072286 |
| Record published | 2021-08-29 |
| Record revised | 2026-06-10 (version 20) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 12 to 107 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -4 to 140 °F; Special storage condition: Keep Dry;This side up;Fragile |
| Distribution end date | 2025-06-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 186-0195-uSF | In distribution | ||
| 186-0195-AMS | In distribution | ||
| DL186-1046 | In distribution | ||
| 186-0199-SLM | In distribution | ||
| 186-0224-USF | In distribution | ||
| 186-0195-uPH | In distribution | ||
| DS186-1046 | In distribution | ||
| 186-0224-NK-RFB | In distribution | ||
| PMB4000ACBL | In distribution | ||
| 186-0195-NK | In distribution | ||
| 186-0106-PH | 9,999 | In distribution | |
| 186-1047 | In distribution | ||
| 186-0224-SF-RFB | In distribution | ||
| 186-0106-PH | 50 | In distribution | |
| PMB4000 | In distribution | ||
| 186-0195-SF | In distribution | ||
| 186-0199-RFB | In distribution | ||
| 186-0195-DM | In distribution | ||
| 186-0224-SLM | In distribution | ||
| 186-0195-PHSPS | In distribution | ||
| 186-0199-GE | In distribution | ||
| 186-0195-MR | In distribution | ||
| 186-1001-JP | In distribution | ||
| DL186-0224-AMS | In distribution | ||
| 186-1046 | In distribution | ||
| 186-0224-SF | In distribution | ||
| DS186-0195-AMS | In distribution | ||
| 186-1001-RFB | In distribution | ||
| 186-0195-SLM | In distribution | ||
| 186-0224-NK | In distribution | ||
| 186-0224-UPH | In distribution | ||
| 186-0199R-SF | In distribution | ||
| 186-0199-SF | In distribution | ||
| DL186-0195-AMS | In distribution | ||
| 186-0224-PHSPS | In distribution | ||
| 186-0224-AMS | In distribution | ||
| 186-0299-RFB | In distribution | ||
| 186-0199-PH | In distribution | ||
| 186-0199-DM | In distribution | ||
| 186-0199R-PH | In distribution | ||
| 186-0224-MR | In distribution | ||
| 186-0224-PH | In distribution | ||
| 186-0199-MR | In distribution | ||
| 186-1002-JP | Withdrawn | ||
| DS186-1049 | Withdrawn | ||
| DS186-0224-AMS | Withdrawn | ||
| 186-0108-RFB | Withdrawn | ||
| 186-0157-PH | Withdrawn | ||
| 186-0195-PH | Withdrawn | ||
| 186-0157-RFB | Withdrawn | ||
| 186-0199-DS | Withdrawn | ||
| 186-0195-GE | Withdrawn | ||
| 186-1030-PH | Withdrawn | ||
| 186-0128 | Withdrawn | ||
| DL186-1049 | Withdrawn | ||
| 186-1005-RFB | Withdrawn | ||
| 186-1002-RFB | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RD Sedline | Masimo Corporation | 2 |
| SedLine | Masimo Corporation | 2 |
| EEG Module w/ Cable | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| B1X5 Software Upgrade | GE Medical Systems Information Technologies, Inc. | 1 |
| BIS Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| BIS module (w accessory kit) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| NeuroSENSE | Neurowave Systems Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260907 | 2026-08-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2018-07-26 | Class II | Device Design | Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems | BIS 46,961; Spare Batteries: 6,937 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.