Jelco
35 catalogue numbers from 982106L-2, listed by ICU Medical, Inc, United States, under Tubes, Vials, Systems, Serum Separators, Blood Collection. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
35catalogue 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) | K081229 |
| Record published | 2017-02-10 |
| Record revised | 2025-04-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 50, case of 200, case of 4, case of 50, case of 100, case of 40 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 982106L-2 | In distribution | ||
| 972512-2 | In distribution | ||
| 96007 | In distribution | ||
| 982306-2 | In distribution | ||
| 972306-2 | In distribution | ||
| 96000S | In distribution | ||
| 982106D-2 | In distribution | ||
| 982112L-2 | In distribution | ||
| 982106-2 | In distribution | ||
| 982306L-2 | In distribution | ||
| 982512-2 | In distribution | ||
| 96005 | In distribution | ||
| 972106-2 | In distribution | ||
| 982512D-2 | In distribution | ||
| 96002S | In distribution | ||
| 982312L-2 | In distribution | ||
| 972506-2 | In distribution | ||
| 4140 | 500 | In distribution | |
| 972312-2 | In distribution | ||
| 4142 | 100 | In distribution | |
| 982312D-2 | In distribution | ||
| 96002 | In distribution | ||
| 982306D-2 | In distribution | ||
| 982106D | In distribution | ||
| 982112D-2 | In distribution | ||
| 4141 | 500 | In distribution | |
| 982312-2 | In distribution | ||
| 982506L-2 | In distribution | ||
| 972112-2 | In distribution | ||
| 982506-2 | In distribution | ||
| 982506D-2 | In distribution | ||
| 982512L-2 | In distribution | ||
| 96000 | In distribution | ||
| 982112-2 | In distribution | ||
| 96004 | In distribution |
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 |
| 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
1 of these is 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 |
|---|---|---|---|---|
| 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 |
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.