Integra®
Integra® Monitor Adaptor Cable, Intracranial Temperature
5manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Integra Lifesciences (Ireland) Limited, Ireland |
|---|---|
| FDA product code | GWM |
| Device type | Device, Monitoring, Intracranial Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1620 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K121573 |
| Record published | 2016-12-29 |
| Record revised | 2025-02-04 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Keep Dry; Storage environment humidity 25 to 80 % RH; Handling environment humidity 30 to 75 % RH; Storage environment temperature -20 to 50 °C; Handling environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ICP-46 | In distribution | |
| BAT1001 | In distribution | |
| ICP-80 | In distribution | |
| ICP-60 | In distribution | |
| ICT-39 | In distribution | |
| ICP-16 | In distribution | |
| ICP-39 | In distribution | |
| CAMCABL | In distribution | |
| ICP-81 | In distribution | |
| PMIOMPM-1 | In distribution | |
| ICP-17 | In distribution | |
| ICP-22 | In distribution | |
| ICT-01 | In distribution | |
| ICP-33 | In distribution | |
| ICP-90 | In distribution | |
| ICP-19 | In distribution | |
| ICP-18 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Licox® | GMS, Gesellschaft für medizinische Sondentechnik mbH | 38 |
| Sophysa | Sophysa | 32 |
| Becker® | Medtronic PS Medical | 31 |
| Codman | Cerenovus, Inc. | 29 |
| Device, Monitoring, Intracranial Pressure | Medtronic PS Medical | 28 |
| Exacta™ | Medtronic PS Medical | 28 |
| Braincare | Braincare Desenvolvimento E Inovacao Tecnologica SA | 24 |
| Camino® | Integra Lifesciences (Ireland) Limited | 20 |
| Codman® | Integra LifeSciences Production Corporation | 19 |
| Aura | Branchpoint & Aura Development LLC | 17 |
| Natus | Natus Medical Incorporated | 15 |
| Duet® | Medtronic PS Medical | 14 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2015-04-14 | Class II | Device Design | Integra LifeSciences Corporation is recalling Integra’s Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. | 1,482 monitors | 2017-12-12 |
| Integra Lifesciences Corporation | 510(k) number | 2015-04-14 | Class II | Device Design | Integra LifeSciences Corporation is recalling Integra’s Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. | 273 monitors | 2017-12-12 |
| Integra Lifesciences Corporation | 510(k) number | 2015-04-14 | Class II | Device Design | Integra LifeSciences Corporation is recalling Integra’s Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. | 59 monitors | 2017-12-12 |
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.