Transpac™
Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Flush 2 and 1 Needleless Valves 1 Bonded
7manufacturers in China registered for this device type
117catalogue 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) | K052828 |
| Record published | 2021-07-28 |
| Record revised | 2021-08-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 10, case of 25, case of 8, case of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 460970462 | In distribution | |
| 46114-24 | In distribution | |
| 46112-12 | In distribution | |
| 46112-08 | In distribution | |
| 46106-91 | In distribution | |
| 46103-77 | In distribution | |
| 460990477 | In distribution | |
| 46103-39 | In distribution | |
| 46110-84 | In distribution | |
| 460100433 | In distribution | |
| 461010416 | In distribution | |
| 460800451 | In distribution | |
| 460680465 | In distribution | |
| 46114-86 | In distribution | |
| 46114-31 | In distribution | |
| 460590429 | In distribution | |
| 460910468 | In distribution | |
| 46106-48 | In distribution | |
| 46104-31 | In distribution | |
| 460970431 | In distribution | |
| 46116-35 | In distribution | |
| 42661-47 | In distribution | |
| 460640454 | In distribution | |
| 460910456 | In distribution | |
| 460830442 | In distribution | |
| 46112-07 | In distribution | |
| 460940411 | In distribution | |
| 46101-64 | In distribution | |
| 460630411 | In distribution | |
| 460700430 | In distribution | |
| 460990410 | In distribution | |
| 460830443 | In distribution | |
| 46114-32 | In distribution | |
| 46112-11 | In distribution | |
| 460800436 | In distribution | |
| 460940447 | In distribution | |
| 460990418 | In distribution | |
| 46112-05 | In distribution | |
| 46113-89 | In distribution | |
| 460700462 | In distribution | |
| 460940416 | In distribution | |
| 46112-03 | In distribution | |
| 461010420 | In distribution | |
| 46117-22 | In distribution | |
| 460910469 | In distribution | |
| 46104-65 | In distribution | |
| 460630405 | In distribution | |
| 46110-46 | In distribution | |
| 46106-47 | In distribution | |
| 460680402 | In distribution | |
| 460650465 | In distribution | |
| 460990455 | In distribution | |
| 46115-52 | In distribution | |
| 46112-10 | In distribution | |
| 460940421 | In distribution | |
| 460970447 | In distribution | |
| 46112-77 | In distribution | |
| 46109-74 | In distribution | |
| 46109-86 | In distribution | |
| 460940420 | In distribution | |
| 460590465 | In distribution | |
| 460880474 | In distribution | |
| 46116-61 | In distribution | |
| 46107-36 | In distribution | |
| 460760453 | In distribution | |
| 460940431 | In distribution | |
| 46104-63 | In distribution | |
| 460970436 | In distribution | |
| 46104-54 | In distribution | |
| 460990471 | In distribution | |
| 460100434 | In distribution | |
| 46116-41 | In distribution | |
| 46110-72 | In distribution | |
| 46104-75 | In distribution | |
| 460680467 | In distribution | |
| 47100-02 | In distribution | |
| 46115-83 | In distribution | |
| 460910404 | In distribution | |
| 460590428 | In distribution | |
| 46101-73 | In distribution | |
| 460700416 | In distribution | |
| 460630403 | In distribution | |
| 461010417 | In distribution | |
| 46104-16 | In distribution | |
| 460670413 | In distribution | |
| 460860420 | In distribution | |
| 460970430 | In distribution | |
| 460910475 | In distribution | |
| 46112-09 | In distribution | |
| 46107-83 | In distribution | |
| 46107-35 | In distribution | |
| 460910431 | In distribution | |
| 460540476 | In distribution | |
| 46104-53 | In distribution | |
| 460910450 | In distribution | |
| 460760421 | In distribution | |
| 46114-81 | In distribution | |
| 460800437 | In distribution | |
| 460880422 | In distribution | |
| 46115-10 | In distribution | |
| 460990466 | In distribution | |
| 46103-68 | In distribution | |
| 460860454 | In distribution | |
| 460940439 | In distribution | |
| 47000-06 | In distribution | |
| 46115-78 | In distribution | |
| 460850419 | In distribution | |
| 46103-72 | In distribution | |
| 46112-14 | In distribution | |
| 46112-13 | In distribution | |
| 460990417 | In distribution | |
| 460990416 | In distribution | |
| 460940418 | In distribution | |
| 46112-47 | In distribution | |
| 460910423 | In distribution | |
| 46110-07 | In distribution | |
| 460800438 | 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 |
| 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
194 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 | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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. | 130 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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. | 380 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 340 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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. | 3060 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 4580 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 2310 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 520 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 3640 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 38160 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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. | 17420 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 800 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 4360 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 1740 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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. | 4470 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 730 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 200 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 3460 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 2240 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 900 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 3020 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 11100 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 2900 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 280 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 820 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 1960 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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. | 200 units | 2017-07-11 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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 |
| ICU Medical, Inc | 510(k) number | 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. | 740 units | 2017-07-11 |
Showing 40 of 194.
Recalls
11 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 | |
| 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 |
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.