Acumen IQ, Vamp
ACUMEN IQ Sensor with VAMP System
7manufacturers in China registered for this device type
1catalogue number
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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | DRS |
| Device type | Transducer, Blood-Pressure, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2850 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K152980 |
| Record published | 2026-05-30 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Store in a cool, dry place; Special storage condition: Keep dry |
| Packaging | Case of 5 |
| Sizes | Length 60 in; total volume 5 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AIQS6AZ5 | Length 60 in | In distribution |
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 Naming This Product
4 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 |
|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 33,327 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 6,714 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 1417 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 11,072 units |
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.