UltiCare
UltiCare Safety Pen Needle 8mm
71manufacturers in China registered for this device type
45catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 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 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Ultimed, Inc., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K140949 |
| Record published | 2016-09-24 |
| Record revised | 2021-02-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Ultiguard of 10, box of 10, box of 100, ultiguard, 90ct-box of 9, healthy accents box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 63004 | In distribution | ||
| 09583 | 100 | In distribution | |
| 09512 | 100 | In distribution | |
| 71015 | 90 | In distribution | |
| 71004 | 100 | In distribution | |
| 09545 | 50 | In distribution | |
| 71006 | 100 | In distribution | |
| 71012 | 90 | In distribution | |
| 99999 | In distribution | ||
| 71003 | 100 | In distribution | |
| 71009 | 30 | In distribution | |
| 71014 | 100 | In distribution | |
| 71005 | 100 | In distribution | |
| 71001 | 90 | In distribution | |
| 63003 | In distribution | ||
| 71011 | 90 | In distribution | |
| 09565 | 50 | In distribution | |
| 71008 | 30 | In distribution | |
| 71007 | 30 | In distribution | |
| 61008 | 100 | In distribution | |
| 09563 | 100 | In distribution | |
| 0414PL | 10 | In distribution | |
| 63008 | In distribution | ||
| 63006 | In distribution | ||
| 63005 | In distribution | ||
| 0335PL | 10 | In distribution | |
| 0435PL | 10 | In distribution | |
| 61005 | 100 | In distribution | |
| 0459PL | 10 | In distribution | |
| 09585 | 50 | In distribution | |
| 0434PL | 10 | In distribution | |
| 71000 | 90 | In distribution | |
| 09562 | 100 | In distribution | |
| 63007 | In distribution | ||
| 0355PL | 10 | In distribution | |
| 71013 | 100 | In distribution | |
| 09543 | 100 | In distribution | |
| 0419PL | 10 | In distribution | |
| 0454PL | 10 | In distribution | |
| 71002 | 90 | In distribution | |
| 09553 | 100 | In distribution | |
| 0315PL | 10 | In distribution | |
| 0439PL | 10 | In distribution | |
| 63014 | In distribution | ||
| 71010 | 90 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213407 | 2021-12-16 |
| K100812 | 2010-06-03 |
| K050464 | 2005-05-11 |
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.