Reli
Reli® 3ML Syringe (Low Dead Space) with Detachable Hypodermic Needle, 20G x 1.5", Regular Wall, Regular Bevel
71manufacturers in China registered for this device type
149catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Myco Medical Supplies, Inc., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K090426 |
| Record published | 2022-05-01 |
| Record revised | 2021-04-07 (version 3) |
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 |
| Packaging | Inner carton of 100, case of 16, case of 8, case of 100, case of 12, case of 5 |
| Sizes | Needle gauge 16 to 30 G; length 0.375 to 2 in; total volume 1 to 10 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SHN27G6251 | Needle Gauge 27 G | In distribution | |
| HYP20G101-RW-S5ML | Total Volume 5 ml | In distribution | |
| SBCN-R21G114T | Length 1.25 in | In distribution | |
| HYP16G101-RW | Needle Gauge 16 G | In distribution | |
| HYP20G101-RW | Needle Gauge 20 G | In distribution | |
| SBCN-R22G114 | Length 1.25 in | 48 | In distribution |
| SHN18G151 | Length 1.5 in | In distribution | |
| SHN21G101 | Needle Gauge 21 G | In distribution | |
| HYP27G051-RW | Needle Gauge 27 G | In distribution | |
| SHN21G101-S10ML | Total Volume 10 ml | In distribution | |
| BCN-R22G151 | Length 1.5 in | 100 | In distribution |
| HYP21G101-RW | Needle Gauge 21 G | In distribution | |
| SHN20G151-S5ML | Total Volume 5 ml | In distribution | |
| SHN25G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SBCN-R20G101T | Length 1 in | In distribution | |
| SHN23G1251-S3ML-LDS | Total Volume 3 ml | In distribution | |
| 169018 M | 100 | In distribution | |
| SBCN-R22G151T | Length 1.5 in | In distribution | |
| SHN22G151-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN20G101-S10ML | Total Volume 10 ml | In distribution | |
| SHN20G101-S5ML | Total Volume 5 ml | In distribution | |
| SHN19G051 | Needle Gauge 19 G | In distribution | |
| SHN26G6251 | Needle Gauge 26 G | In distribution | |
| SHN22G101-S3ML | Total Volume 3 ml | In distribution | |
| HYP20G101-RW-S3ML | Total Volume 3 ml | In distribution | |
| SHN21G101-S5ML | Total Volume 5 ml | In distribution | |
| SHN22G1251 | Needle Gauge 22 G | In distribution | |
| SHN22G151 | Length 1.5 in | In distribution | |
| SHN21G151-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN25G6251-S1ML-LDS | Total Volume 1 ml | In distribution | |
| SHN23G101-S1ML-LDS | Total Volume 1 ml | In distribution | |
| HYP20G151-RW | Needle Gauge 20 G | In distribution | |
| BCN-R21G151 | Length 1.5 in | 100 | In distribution |
| SHN20G101 | Needle Gauge 20 G | In distribution | |
| SHN19G151-S3ML-LDS | Total Volume 3 ml | In distribution | |
| NS-BCTH | 100 | In distribution | |
| SHN19G101 | Needle Gauge 19 G | In distribution | |
| SHN27G051-S1ML-LDS | Total Volume 1 ml | In distribution | |
| SHN18G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SBCN-R21G114 | Length 1.25 in | 48 | In distribution |
| SBCN-R22G114T | Length 1.25 in | In distribution | |
| SBCN-R20G151T | Length 1.5 in | In distribution | |
| HYP19G101-TW | Needle Gauge 19 G | In distribution | |
| SHN24G151 | Needle Gauge 24 G | In distribution | |
| SHN25G101-S1ML-LDS | Total Volume 1 ml | In distribution | |
| BCN-R21G114 | Length 1.25 in | 100 | In distribution |
| SHN26G051 | Needle Gauge 26 G | In distribution | |
| HYP25G6251-TW-S3ML | Total Volume 3 ml | In distribution | |
| SHN19G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| HYP20G101-RW-S10ML | Total Volume 10 ml | In distribution | |
| SHN21G151-S10ML | Total Volume 10 ml | In distribution | |
| SHN27G0751 | Needle Gauge 27 G | In distribution | |
| SBCN-R20G101 | Length 1 in | 48 | In distribution |
| HYP27G151-RW | Needle Gauge 27 G | In distribution | |
| SHN25G6251-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SBCN-R20G114T | Length 1.25 in | In distribution | |
| HYP30G051-RW | Needle Gauge 30 G | In distribution | |
| SHN23G051 | Needle Gauge 23 G | In distribution | |
| SHN22G151-S10ML | Total Volume 10 ml | In distribution | |
| SHN25G101-S1ML | Total Volume 1 ml | In distribution | |
| BCN-R20G114 | Length 1.25 in | 100 | In distribution |
| SHN25G101 | Needle Gauge 25 G | In distribution | |
| SBCN-R20G151 | Length 1.5 in | 48 | In distribution |
| SHN20G151-S10ML | Total Volume 10 ml | In distribution | |
| SHN23G151 | Needle Gauge 23 G | In distribution | |
| SHN23G101 | Length 1 in | In distribution | |
| SHN22G151-S5ML | Total Volume 5 ml | In distribution | |
| HYP25G151-RW | Needle Gauge 25 G | In distribution | |
| HYP22G151-RW | Needle Gauge 22 G | In distribution | |
| SHN19G201 | Needle Gauge 19 G | In distribution | |
| SHN21G051 | Needle Gauge 21 G | In distribution | |
| HYP25G101-RW | Needle Gauge 25 G | In distribution | |
| SHN22G101 | Needle Gauge 22 G | In distribution | |
| SHN25G625 | Needle Gauge 25 G | In distribution | |
| SHN20G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN27G1251 | Needle Gauge 27 G | In distribution | |
| SHN27G6251-S1ML-LDS | Total Volume 1 ml | In distribution | |
| SBCN-R20G114 | Length 1.25 in | 48 | In distribution |
| SHN23G6251 | Needle Gauge 23 G | In distribution | |
| SHN30G051-S1ML-LDS | Total Volume 1 ml | In distribution | |
| HYP27G1251-RW | Needle Gauge 27 G | In distribution | |
| BCN-R20G151 | Length 1.5 in | 100 | In distribution |
| SHN22G051 | Needle Gauge 22 G | In distribution | |
| SHN26G101 | Needle Gauge 26 G | In distribution | |
| BCN-R22G114 | Length 1.25 in | 100 | In distribution |
| SHN27G151 | Needle Gauge 27 G | In distribution | |
| HYP20G151-RW-S3ML | Total Volume 3 ml | In distribution | |
| HYP25G6251-TW-S1ML | Total Volume 1 ml | In distribution | |
| HYP18G101-RW | Needle Gauge 18 G | In distribution | |
| HYP16G151-RW | Needle Gauge 16 G | In distribution | |
| SBCN-R21G151T | Length 1.5 in | In distribution | |
| SBCN-R22G101 | Length 1 in | 48 | In distribution |
| HYP27G051-RW-S1ML | Total Volume 1 ml | In distribution | |
| GSBCS25G-12 | Needle Gauge 25 G | In distribution | |
| HYP25G6251-RW | Needle Gauge 25 G | In distribution | |
| HYP21G151-RW | Needle Gauge 21 G | In distribution | |
| SHN18G101-S1ML-LDS | Total Volume 1 ml | In distribution | |
| SHN18G051 | Needle Gauge 18 G | In distribution | |
| SHN30G051 | Needle Gauge 30 G | In distribution | |
| SBCN-R21G151 | Length 1.5 in | 48 | In distribution |
| SHN22G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN18G101 | Needle Gauge 18 G | In distribution | |
| HYP18G151-TW | Needle Gauge 18 G | In distribution | |
| SHN23G101-S1ML | Total Volume 1 ml | In distribution | |
| SHN23G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN20G201 | Needle Gauge 20 G | In distribution | |
| SHN20G051 | Needle Gauge 20 G | In distribution | |
| SHN24G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN27G101 | Needle Gauge 27 G | In distribution | |
| SHN27G051 | Needle Gauge 27 G | In distribution | |
| HYP18G151-RW | Needle Gauge 18 G | In distribution | |
| SHN19G151 | Needle Gauge 19 G | In distribution | |
| BCN-R22G101 | Length 1 in | 100 | In distribution |
| SHN21G6251 | Needle Gauge 21 G | In distribution | |
| HYP30G101-RW | Needle Gauge 30 G | In distribution | |
| BCN-R20G101 | Length 1 in | 100 | In distribution |
| SHN25G151-S3ML-LDS | Total Volume 3 ml | In distribution | |
| HYP19G151-TW | Needle Gauge 19 G | In distribution | |
| SHN24G051 | Needle Gauge 24 G | In distribution | |
| SHN23G151-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SHN23G1251 | Needle Gauge 23 G | In distribution | |
| SHN21G151 | Needle Gauge 21 G | In distribution | |
| SHN25G151 | Needle Gauge 25 G | In distribution | |
| SHN21G151-S5ML | Total Volume 5 ml | In distribution | |
| HYP22G101-RW-S3ML | Total Volume 3 ml | In distribution | |
| SHN21G1251 | Needle Gauge 21 G | In distribution | |
| SBCN-R22G101T | Length 1 in | In distribution | |
| HYP18G151-RW-SB | Needle Gauge 18 G | In distribution | |
| SHN26G3751 | Needle Gauge 26 G | In distribution | |
| SHN25G6251 | Length 0.625 in | In distribution | |
| SHN18G151-S3ML-LDS | Total Volume 3 ml | In distribution | |
| SBCN-R22G151 | Length 1.5 in | 48 | In distribution |
| SHN24G101 | Needle Gauge 24 G | In distribution | |
| SHN26G151 | Needle Gauge 26 G | In distribution | |
| SBCN-R21G101T | Length 1 in | In distribution | |
| SHN18G201 | Needle Gauge 18 G | In distribution | |
| HYP22G151-RW-S3ML | Total Volume 3 ml | In distribution | |
| SHN25G051 | Needle Gauge 25 G | In distribution | |
| HYP21G101-TW-S3ML | Total Volume 3 ml | In distribution | |
| SHN20G151-S3ML-LDS | Needle Gauge 20 G | In distribution | |
| HYP23G101-TW-S3ML | Total Volume 3 ml | In distribution | |
| SBCN-R21G101 | Length 1 in | 48 | In distribution |
| SHN23G101-S3ML | Total Volume 3 ml | In distribution | |
| SBCTH-Orange | 50 | In distribution | |
| GSBCS23G-12 | Needle Gauge 23 G | In distribution | |
| SHN20G151 | Needle Gauge 20 G | In distribution | |
| SHN21G101-S3ML-LDS | Total Volume 3 ml | In distribution | |
| BCN-R21G101 | Length 1 in | 100 | In distribution |
| HYP21G101-RW-S5ML | Total Volume 5 ml | 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 |
| 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 |
| Needle, Hypodermic, Single Lumen | Becton, Dickinson AND Company | 76 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173279 | 2018-05-14 |
| K090426 | 2009-06-12 |
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 | Closed |
|---|---|---|---|---|---|
| 2015-11-06 | Class II | Under Investigation by firm | Particulates: Complaints of rubber coring from the closure of injection vials. | 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs) | 2017-05-03 |
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.