Medex
225 catalogue numbers from MX961Z06, listed by ICU Medical, 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
225catalogue numbers in this listing
40recalls 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 | ICU Medical, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K820355 |
| Record published | 2016-10-12 |
| Record revised | 2025-06-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 10, case of 20, case of 25, case of 50, box of 20 |
| Distribution end date | 2020-10-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX961Z06 | In distribution | |
| MXG300273 | In distribution | |
| MX9614 | In distribution | |
| MXG300263 | In distribution | |
| MX961Z14 | In distribution | |
| MX961Z99 | In distribution | |
| MX951H212 | In distribution | |
| MX961Z28 | In distribution | |
| MX961Z01 | In distribution | |
| MX964Z81 | In distribution | |
| MX962Z19 | In distribution | |
| MX964Z08 | In distribution | |
| MX963Z08 | In distribution | |
| MX9616 | In distribution | |
| MX9625H004C1 | In distribution | |
| MX961Z04 | In distribution | |
| MX960 | In distribution | |
| MX9601A | In distribution | |
| MX961Z13 | In distribution | |
| MX9630A | In distribution | |
| MX962R181 | In distribution | |
| MX962Z42 | In distribution | |
| MX20330 | In distribution | |
| MX97005 | In distribution | |
| MX961Z62 | In distribution | |
| M20178R2 | In distribution | |
| MX961H182 | In distribution | |
| MX962Z68 | In distribution | |
| MX7950 | In distribution | |
| MX5428R2 | In distribution | |
| MX962Z81 | In distribution | |
| MX964Z19 | In distribution | |
| MX961Z19 | In distribution | |
| MX961Z23 | In distribution | |
| MX401H212 | In distribution | |
| MX20394 | In distribution | |
| MX962Z05 | In distribution | |
| MX952R181 | In distribution | |
| MX9631A | In distribution | |
| MX20297R1 | In distribution | |
| MX962Z74 | In distribution | |
| MX961H212 | In distribution | |
| MX963Z19 | In distribution | |
| MX962H181 | In distribution | |
| MX20775 | In distribution | |
| MX963Z62 | In distribution | |
| MX961Z44 | In distribution | |
| MX964Z78 | In distribution | |
| M20171 | In distribution | |
| MX963Z42 | In distribution | |
| MX963Z47 | In distribution | |
| MX962Z70 | In distribution | |
| MX964Z15 | In distribution | |
| MX961Z02 | In distribution | |
| MX961Z47 | In distribution | |
| MX962R181 | In distribution | |
| MX961Z29 | In distribution | |
| MX962Z50 | In distribution | |
| MX962Z53 | In distribution | |
| MX9615H000C1 | In distribution | |
| MX962Z72 | In distribution | |
| MX961Z70 | In distribution | |
| MX9615H001C1 | In distribution | |
| MX961Z67 | In distribution | |
| MX962Z62 | In distribution | |
| MX963Z03 | In distribution | |
| MX963Z29 | In distribution | |
| MX962Z29 | In distribution | |
| MX9644 | In distribution | |
| MX951R181 | In distribution | |
| MX961Z50 | In distribution | |
| MX962Z03 | In distribution | |
| MX964Z02 | In distribution | |
| MX961Z18 | In distribution | |
| MX951H211 | In distribution | |
| MX961H211 | In distribution | |
| MX964Z68 | In distribution | |
| MX9602J | In distribution | |
| MX961Z73 | In distribution | |
| MX401R151 | In distribution | |
| MX20490 | In distribution | |
| MX961Z02P1 | In distribution | |
| MX962Z08 | In distribution | |
| MX962Z04 | In distribution | |
| MX964Z37 | In distribution | |
| MX963Z81 | In distribution | |
| MX20740 | In distribution | |
| MX961H181 | In distribution | |
| MX963Z14 | In distribution | |
| MX962Z01 | In distribution | |
| MX20550 | In distribution | |
| MX962Z02 | In distribution | |
| MX951H181 | In distribution | |
| MX963Z01 | In distribution | |
| MX963Z22 | In distribution | |
| MX951H182 | In distribution | |
| MX20956 | In distribution | |
| MX952H181 | In distribution | |
| MX961Z37 | In distribution | |
| MX961Z21 | In distribution | |
| MX964Z24 | In distribution | |
| MXG300247 | In distribution | |
| MX963Z50 | In distribution | |
| MX963Z02 | In distribution | |
| MX964Z29 | In distribution | |
| MXG300246 | In distribution | |
| MX962H182 | In distribution | |
| MX961Z81 | In distribution | |
| MX963Z05 | In distribution | |
| MX961Z20 | In distribution | |
| MX962Z15 | In distribution | |
| MX962Z22 | In distribution | |
| MX9635H002C1 | In distribution | |
| MX20408 | In distribution | |
| MX401R061 | In distribution | |
| MX961Z78 | In distribution | |
| MX961H181 | In distribution | |
| MX7328R2 | In distribution | |
| MX952H182 | In distribution | |
| MX964Z42 | In distribution | |
| MX961Z08 | In distribution | |
| MX963Z37 | In distribution | |
| MX963Z78 | In distribution | |
| MX9604A | In distribution | |
| MX961R181 | In distribution | |
| MX97003 | In distribution | |
| MX9606A | In distribution | |
| MX963Z04 | In distribution | |
| MX961Z68 | In distribution | |
| MX960X2SCJ | In distribution | |
| MX964Z53 | In distribution | |
| MX961Z42 | In distribution | |
| MX964Z14 | In distribution | |
| MX20700 | In distribution | |
| MX9605A | In distribution | |
| MX9604J | In distribution | |
| MX962Z47 | In distribution | |
| MX951H211 | In distribution | |
| MX9602A | In distribution | |
| MX960XX | In distribution | |
| MX961R181 | In distribution | |
| MX961Z25 | In distribution | |
| MX20509 | In distribution | |
| MX963Z15 | In distribution | |
| MX951H181 | In distribution | |
| MX952R181 | In distribution | |
| MX9645 | In distribution | |
| MX20758 | In distribution | |
| MX961Z80 | In distribution | |
| MX952H181 | In distribution | |
| MX20721 | In distribution | |
| MX961Z03 | In distribution | |
| MX962Z37 | In distribution | |
| M20553 | In distribution | |
| MX960SCFA | In distribution | |
| MX961Z34 | In distribution | |
| MX960XY | In distribution | |
| MX961Z79 | In distribution | |
| MX401R151 | In distribution | |
| MX962Z02P1 | In distribution | |
| MX962Z78 | In distribution | |
| MX961Z69 | In distribution | |
| MX961Z74 | In distribution | |
| MX961H211 | In distribution | |
| MX9606J | In distribution | |
| MX964Z62 | In distribution | |
| MX962Z64 | In distribution | |
| MX9625H002C1 | In distribution | |
| MX962H181 | In distribution | |
| MXG300141 | In distribution | |
| MX962Z14 | In distribution | |
| MX953H182 | In distribution | |
| MX963Z68 | In distribution | |
| MX961Z15 | In distribution | |
| MX951R181 | In distribution | |
| MX963Z64 | In distribution | |
| MXG300264 | In distribution | |
| M20754 | In distribution | |
| MX961Z05 | In distribution | |
| MX960X2SC | In distribution | |
| MX20551 | In distribution | |
| MX20333 | In distribution | |
| MX963H182 | In distribution | |
| MX961Z22 | In distribution | |
| MX962Y68 | In distribution | |
| MX20549 | In distribution | |
| MX700327 | In distribution | |
| MX20449 | In distribution | |
| MX961Z64 | In distribution | |
| MX961Z102 | In distribution | |
| MX20157R1 | In distribution | |
| MG300218 | In distribution | |
| MG300222R1 | In distribution | |
| MX90175 | Withdrawn | |
| MX90017 | Withdrawn | |
| MX90012 | Withdrawn | |
| MX90013 | Withdrawn | |
| MX94050 | Withdrawn | |
| MX90034 | Withdrawn | |
| MX90125 | Withdrawn | |
| MX90174 | Withdrawn | |
| MX90042 | Withdrawn | |
| MX7896R1 | Withdrawn | |
| MX90015 | Withdrawn | |
| MX90173 | Withdrawn | |
| MX90137 | Withdrawn | |
| MX90108 | Withdrawn | |
| MX848X2SC | Withdrawn | |
| MX90119 | Withdrawn | |
| MX848P1 | Withdrawn | |
| MX90020 | Withdrawn | |
| MX90157 | Withdrawn | |
| MX90008 | Withdrawn | |
| MX8004T | Withdrawn | |
| MX90167 | Withdrawn | |
| MX90044 | Withdrawn | |
| MX90028 | Withdrawn | |
| MX90167 | Withdrawn | |
| MX90163 | Withdrawn | |
| MX90158 | Withdrawn | |
| MX858P1 | Withdrawn | |
| MX90164 | Withdrawn | |
| MX90147 | Withdrawn | |
| MX90006 | Withdrawn | |
| MX90118 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 381 |
| 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 |
| Unimed | Unimed Medical Supplies Inc | 17 |
Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | UDI-DI | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 260 units |
| ICU Medical, Inc | 510(k) number | 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total |
Recalls
39 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 |
|---|---|---|---|---|---|
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total | |
| 2018-11-27 | Class II | Process design | Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separ | 5000 | 2022-02-01 |
| 2018-11-27 | Class II | Process design | Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separ | 2022-02-01 | |
| 2018-11-27 | Class II | Process design | Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separ | 280 | 2022-02-01 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 135 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 2200 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 150 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 750 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 1100 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 40 | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 125 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 370 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 30 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 100 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 100 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 100 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 144 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 3480 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 20 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 500 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 260 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 60,560 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 70 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 175 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 60 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 710 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 660 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 275 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 295 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 140 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 60 units | 2017-07-11 |
| 2016-09-27 | Class II | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | 560 units | 2017-07-11 |
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.