Immulite® 2000 Systems Microsampling Tube Holder Set
Microsampling Insert - IMMULITE - CONS - 15 Pieces
23manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Rongye Technology Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 16 |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 11 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
Showing 12 of 23. All 23 manufacturers in China registered for Tubes, Vials, Systems, Serum Separators, Blood Collection
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | JKA |
| Device type | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1675 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K952516 |
| Record published | 2016-09-24 |
| Record revised | 2023-11-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2019-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10385209 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 182 |
| S-Monovette® | Sarstedt Aktiengesellschaft & Co.KG | 108 |
| Vacuette | Greiner BIO-ONE Gmbh | 106 |
| Jelco | ICU Medical, Inc | 35 |
| Kbmed | KB Medical (Group) Inc. | 33 |
| Marketlab Inc | Marketlab Incorporated | 30 |
| Maveric Medical | Maveric Medical LLC | 27 |
| Safe-T-Fill® | Ram Scientific | 23 |
| Improvacuter® Gel & Clot Activator Tube | Guangzhou Improve Medical Instruments Co., Ltd. | 21 |
| Medline | Medline Industries, Inc. | 20 |
| Kurin Blood Culture Collection Set | Kurin, Inc. | 20 |
| Reli | Myco Medical Supplies, Inc. | 18 |
Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection
Recalls Naming This Product
31 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 | 2025-12-19 | Class II | Under Investigation by firm | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. | 64290 total | |
| Smiths Medical Asd, Inc. | 510(k) number | 2023-09-06 | Class II | Process control | The complaint involved the absence of a component called “ASM Filter-Pro ABG SYR CAP” from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and L | 31900 devices | |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-01-07 | Class II | Process control | Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. | 720,100 total devices | 2020-12-14 |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-01-07 | Class II | Process control | Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. | 127,700 total devices | 2020-12-14 |
| Smiths Medical Asd, Inc. | 510(k) number | 2018-06-22 | Class II | Under Investigation by firm | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating. | Approx. 28,578,939 kits for both products | 2020-10-05 |
| Smiths Medical Asd, Inc. | 510(k) number | 2018-06-22 | Class II | Under Investigation by firm | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating. | Approx. 28,578,939 kits for both products | 2020-10-05 |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-12-17 | Class III | Employee error | The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year. | 900 units | 2015-06-25 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-11-22 | Class II | Component change control | issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes | 2020-11-20 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 340,000 | 2012-05-08 |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 7000 for all custom | 2012-05-08 |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2004-09-09 | Not classified | Other | Sterility of the device is compromised due to packaging defects | 2012-05-08 |
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.