Jelco
16 catalogue numbers from 4428-5, listed by ICU Medical, Inc, United States, under Syringe, Antistick. 39 manufacturers in China are registered for this product code.
39manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (10), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 11 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Wellmien Healthcare Tech.(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 22 |
Showing 12 of 39. All 39 manufacturers in China registered for Syringe, Antistick
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | MEG |
| Device type | Syringe, Antistick |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K063755 |
| Record published | 2017-01-17 |
| Record revised | 2025-04-17 (version 4) |
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 100, case of 6, box of 50, case of 8, case of 400 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4428-5 | In distribution | |
| 4426-TB | In distribution | |
| 4429-3 | In distribution | |
| 4425-TB | In distribution | |
| 432510 | In distribution | |
| 4428-1 | In distribution | |
| 4429-1 | In distribution | |
| 4429-5 | In distribution | |
| 4427-TB | In distribution | |
| 432310 | In distribution | |
| 412510 | In distribution | |
| 4430-5 | In distribution | |
| 432315 | In distribution | |
| 432210 | In distribution | |
| 4430-3 | In distribution | |
| 432558 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SURGUARD2 | Terumo (Philippines) Corporation | 59 |
| VanishPoint® | Retractable Technologies, Inc. | 51 |
| EasyTouch | MHC Medical Products | 50 |
| McKesson | Mckesson Medical-Surgical Inc. | 47 |
| Wealy® Reli® | Myco Medical Supplies, Inc. | 39 |
| SOL-Care™ Luer Lock Safety Syringe with Exchangeable Needle | Sol-Millennium Medical, Inc. | 29 |
| Securegard | SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag | 24 |
| Syringe with safety needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 20 |
| SURGUARD3 | Terumo (Philippines) Corporation | 20 |
| Reli | Myco Medical Supplies, Inc. | 17 |
| SOL-Care™ Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | 17 |
| Syringe with needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 16 |
Showing 12 of 106. All products under Syringe, Antistick
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2021-05-17 | Class I | Process control | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward. | 1,432,200 units | 2023-10-11 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-07-10 | Class II | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes | 363015 | 2021-09-15 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-07-10 | Class II | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes | 93700 | 2021-09-15 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-07-10 | Class II | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes | 506925 | 2021-09-15 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-07-10 | Class II | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes | 108000 | 2021-09-15 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-07-10 | Class II | Storage | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes | 54000 | 2021-09-15 |
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.