ViewFlex™
Catheter Interface Module
1manufacturer
7catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. 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 |
Record
| Listed by | St. Jude Medical, United States |
|---|---|
| FDA product code | DRJ |
| Device type | System, Signal Isolation |
| Device class | Class 1 |
| Regulation | 21 CFR 870.2600 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-05-06 |
| Record revised | 2024-01-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -13 to 140 °F; Handling environment temperature 50 to 95 °F; Storage environment humidity 15 to 90 % RH; Storage environment temperature -25 to 60 °C; Special storage condition: Keep dry; Handling environment temperature 10 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H701375 | In distribution | |
| 100072496 | In distribution | |
| H701374-R | In distribution | |
| H700296 | In distribution | |
| H701375-R | In distribution | |
| 100043720 | In distribution | |
| H701374 | In distribution |
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.