Triple Pressure Kit
2 catalogue numbers from 042951705F, listed by Argon Medical Devices, Inc., United States, under Transducer, Blood-Pressure, Extravascular. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
2catalogue numbers in this listing
9recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (1), Shandong (1). 2 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 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | DRS |
| Device type | Transducer, Blood-Pressure, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2026-05-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5, box of 10 |
| Distribution end date | 2024-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 042951705F | Withdrawn | |
| 042942601B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 381 |
| Medex | ICU Medical, Inc | 225 |
| Biotrans™ Pressure Monitoring Kits | Bioptimal International Pte. Ltd. | 134 |
| Transpac™ | ICU Medical, Inc | 117 |
| Antmed | Shenzhen Antmed Co., Ltd. | 96 |
| Namic | Navilyst Medical, Inc. | 60 |
| Namic | Medline Industries, Inc. | 58 |
| Transpac™/Transtar™ | ICU Medical, Inc | 58 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 28 |
| Centurion | Centurion Medical Products Corporation | 23 |
| Transducer, Blood-Pressure, Extravascular | Utah Medical Products, Inc. | 22 |
| Deltran | Utah Medical Products, Inc. | 22 |
Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
| 2018-10-16 | Class II | Equipment maintenance | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | Total number in recall for all products in dist: 49,130 unit | 2021-06-15 |
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.