Computer, Blood-Pressure
Nibp - Tubing, Coiled, Bayonet, UDI
12manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (1), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | Guangdong | Specification developer | 7 |
Record
| Listed by | Physio-Control, Inc., United States |
|---|---|
| FDA product code | DSK |
| Device type | Computer, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1110 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142430 |
| Record published | 2018-10-16 |
| Record revised | 2024-10-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 6 to 12 ft |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21300 | Length 12.0 ft | In distribution |
| 21300 | Length 10.0 ft | In distribution |
| 21300 | Length 9.0 ft | In distribution |
| 21300 | Length 6.0 ft | In distribution |
| 21300 | Length 12.0 ft | In distribution |
| 21300 | Length 9.0 ft | In distribution |
| 21300 | Length 10.0 ft | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Computer, Blood-Pressure | St. Jude Medical | 39 |
| Zurich Medical Accessory Cable | Zurich Medical Inc | 33 |
| M Series CCT | Zoll Medical Corporation | 33 |
| PressureWire™ | St. Jude Medical | 11 |
| Propaq M | Zoll Medical Corporation | 10 |
| Safedraw™ | Argon Critical Care Systems Singapore PTE. Ltd. | 8 |
| SJM™ | St. Jude Medical | 4 |
| Quantien™ | St. Jude Medical | 4 |
| SureSigns VSi | Philips Medical Systems Hsg | 3 |
| Avvigo™ Guidance System | Boston Scientific Corporation | 2 |
| SureSigns VS2+ | Philips Medical Systems Hsg | 2 |
| X Series | Zoll Medical Corporation | 2 |
Showing 12 of 36. All products under Computer, Blood-Pressure
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.