Vamp Plus
VAMP Plus is a closed, needleless blood-sampling system attached to arterial or central venous catheters and pressure-monitoring lines. It works with disposable or reusable pressure…
VAMP Plus is a closed, needleless blood-sampling system attached to arterial or central venous catheters and pressure-monitoring lines. It works with disposable or reusable pressure transducers.
Before sampling, the system retains the diluted blood and flush solution from the line as a clearing volume. An undiluted sample can then be drawn from the in-line site, and the retained clearing volume is returned to the patient.
Listed Item
Blood Management System.
Tubing and Sampling Sites
The described configuration uses PVC tubing with DINCH nonphthalate plasticizer and electron-beam sterilization. Some models use a Luer-activated sampling site in place of the Z-site. The sterile system is supplied for single use and periodic blood withdrawal.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K181684 |
| Record published | 2016-09-03 |
| Record revised | 2018-11-28 (version 4) |
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 |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
| Packaging | Shipper of 10 |
| Sizes | Length 17 to 91 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VP1 | Length 60 in | In distribution |
| VP181Z | Length 17 in | In distribution |
| VP2 | Length 60 in | In distribution |
| VP0753 | Length 91 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181684 | 2018-11-08 |
| K180275 | 2018-10-24 |
| K173586 | 2018-04-05 |
| K161962 | 2016-11-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2013-01-30 | Class II | Process change control | The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. | 30,467 | 2016-03-10 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-02-09 | Not classified | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”. | 2,728 units | 2011-04-11 |
| 2009-02-09 | Not classified | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”. | 107 units | 2011-04-11 |
| 2009-02-09 | Not classified | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”. | 35 units | 2011-04-11 |
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.