Portex
GTIN for 4042-2, 1/EA
23manufacturers in China registered for this device type
182catalogue numbers in this listing
1510(k) clearance
1recall
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 | ICU Medical, Inc, United States |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K952516 |
| Record published | 2017-01-06 |
| Record revised | 2025-04-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 100, case of 200, case of 4, box of 25, box of 50, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G1632 | In distribution | |
| 11770-01 | In distribution | |
| G1293 | In distribution | |
| G1744 | In distribution | |
| 4077NP-1 | In distribution | |
| G1675 | In distribution | |
| 4084P-1 | In distribution | |
| 4645P-2 | In distribution | |
| G1563 | In distribution | |
| G1784 | In distribution | |
| G1725 | In distribution | |
| 4903 | In distribution | |
| 4058NP-2 | In distribution | |
| 4041W-2 | In distribution | |
| 4590PG | In distribution | |
| 4619LH | In distribution | |
| G1661 | In distribution | |
| G1754 | In distribution | |
| 4620P-1 | In distribution | |
| G1494 | In distribution | |
| G1749 | In distribution | |
| 4042-2 | In distribution | |
| 4558PG | In distribution | |
| G1796 | In distribution | |
| G1797 | In distribution | |
| G1028 | In distribution | |
| G1763 | In distribution | |
| 4619PG | In distribution | |
| 4599P-1 | In distribution | |
| G1218 | In distribution | |
| G1719 | In distribution | |
| G1488 | In distribution | |
| 4042LH | In distribution | |
| G1511 | In distribution | |
| 4611LH | In distribution | |
| G1742 | In distribution | |
| 4698PE | In distribution | |
| 4591EG-1 | In distribution | |
| 4699LH | In distribution | |
| 4660P-1 | In distribution | |
| G1392 | In distribution | |
| G1732 | In distribution | |
| G1581 | In distribution | |
| G1671 | In distribution | |
| 4591P-1 | In distribution | |
| G1726 | In distribution | |
| G1437 | In distribution | |
| G2001 | In distribution | |
| G1325 | In distribution | |
| G1504 | In distribution | |
| 4646E | In distribution | |
| G1713 | In distribution | |
| G1807 | In distribution | |
| 4036-2 | In distribution | |
| 4698PG | In distribution | |
| G1777 | In distribution | |
| G1806 | In distribution | |
| G1771 | In distribution | |
| G1699 | In distribution | |
| G1724 | In distribution | |
| 4900 | In distribution | |
| G1776 | In distribution | |
| G1438 | In distribution | |
| G1695 | In distribution | |
| G1773 | In distribution | |
| G1787 | In distribution | |
| 4629P-2 | In distribution | |
| 4046-2 | In distribution | |
| G1804 | In distribution | |
| 4699P-1 | In distribution | |
| 4645PE | In distribution | |
| G1193 | In distribution | |
| 4904 | In distribution | |
| 4558PE | In distribution | |
| G1509 | In distribution | |
| 4043E | In distribution | |
| G1751 | In distribution | |
| 4044EG-1 | In distribution | |
| G1459J | In distribution | |
| 4057NP-1 | In distribution | |
| 4078-2 | In distribution | |
| 4619PE | In distribution | |
| 4617P-1 | In distribution | |
| 4620EG-1 | In distribution | |
| G1412 | In distribution | |
| G1108 | In distribution | |
| G1759 | In distribution | |
| G1700 | In distribution | |
| G1803 | In distribution | |
| 4588P-2 | In distribution | |
| 4053-2 | In distribution | |
| 4590P-2 | In distribution | |
| G1649 | In distribution | |
| 4629PG | In distribution | |
| G1482 | In distribution | |
| 4650P-1 | In distribution | |
| G1689 | In distribution | |
| 4598P-2 | In distribution | |
| 4610LH | In distribution | |
| G1814 | In distribution | |
| G1469J | In distribution | |
| 4611P-1 | In distribution | |
| 4041-2 | In distribution | |
| G1465J | In distribution | |
| G1650 | In distribution | |
| G1698 | In distribution | |
| 4046E | In distribution | |
| 4698P-2 | In distribution | |
| G1470J | In distribution | |
| G1716 | In distribution | |
| 4041E | In distribution | |
| G1654 | In distribution | |
| G1585 | In distribution | |
| G1586 | In distribution | |
| 4645PG | In distribution | |
| G1039 | In distribution | |
| G1477 | In distribution | |
| 4078EG-2 | In distribution | |
| G1676 | In distribution | |
| 4040-2 | In distribution | |
| 4042E | In distribution | |
| 4616E | In distribution | |
| 4646-2 | In distribution | |
| G1462J | In distribution | |
| G1467J | In distribution | |
| 4619EG-2 | In distribution | |
| G1548 | In distribution | |
| G1461J | In distribution | |
| G1786 | In distribution | |
| G1702 | In distribution | |
| G1778 | In distribution | |
| 4589P-1 | In distribution | |
| 4698LH | In distribution | |
| 4610P-2 | In distribution | |
| 4629PE | In distribution | |
| G1709 | In distribution | |
| G1712 | In distribution | |
| G1736 | In distribution | |
| 4660EG-1 | In distribution | |
| 4044P-1 | In distribution | |
| G1464J | In distribution | |
| G1374 | In distribution | |
| G1463J | In distribution | |
| G1634 | In distribution | |
| G1568 | In distribution | |
| G1762 | In distribution | |
| 4648PE | In distribution | |
| G1783 | In distribution | |
| 4346-2 | In distribution | |
| 4039EG-1 | In distribution | |
| 4080P-2 | In distribution | |
| G1813 | In distribution | |
| 4618PE | In distribution | |
| G1519 | In distribution | |
| 4640P-1 | In distribution | |
| G1285 | In distribution | |
| A4114 | In distribution | |
| 4080PG | In distribution | |
| G1575 | In distribution | |
| G1756 | In distribution | |
| G1460J | In distribution | |
| 4658PE | In distribution | |
| 4645EG-2 | In distribution | |
| 4080PE | In distribution | |
| 4077EG-1 | In distribution | |
| 4041LH | In distribution | |
| G1832 | In distribution | |
| 4649P-1 | In distribution | |
| G1792 | In distribution | |
| G1481 | In distribution | |
| 4640LH | In distribution | |
| 4628PE | In distribution | |
| G1812 | In distribution | |
| G1468J | In distribution | |
| G1466J | In distribution | |
| 4039-1 | In distribution | |
| 4905 | In distribution | |
| 4616-2 | In distribution | |
| 4598EG-2 | In distribution | |
| G1706 | In distribution | |
| G1570 | In distribution | |
| G1665 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| icu medical | Jiangsu Caina Medical Co., Ltd. | 18 |
Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881201 | 1988-05-16 |
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.