Terumo
The TERUMO Needle is a sterile, single-lumen hypodermic needle intended to inject fluids into or withdraw fluids from parts of the body below the skin. The FDA filing identifies the subject…
The TERUMO Needle is a sterile, single-lumen hypodermic needle intended to inject fluids into or withdraw fluids from parts of the body below the skin. The FDA filing identifies the subject device as the TERUMO Needle.
The filing describes a sharpened stainless-steel tube joined to a female luer hub. The hub is designed to connect with a male connector on a piston syringe or an intravascular administration set.
Listed Item
TERUMO Needle
Needle Construction
The filing describes the needle as manually operated and lists multiple needle sizes and lengths. The exact configuration depends on the needle code listed for the device.
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 | Terumo (Philippines) Corporation, Philippines |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Manufacturer |
| 510(k) | K121607 |
| Record published | 2016-09-14 |
| Record revised | 2019-10-23 (version 6) |
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 |
| Storage | Special storage condition: Do not store at extreme temperature and humidity. |
| Packaging | Inner carton of 10, outer carton of 10 |
| Sizes | Needle gauge 18 to 30 G; length 0.5 to 1.5 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NN1938R | Needle Gauge 19 G | 100 | In distribution |
| NN2025R | Length 1 in | 100 | In distribution |
| NN2713R | Needle Gauge 27 G | 100 | In distribution |
| NN2516R | Needle Gauge 25 G | 100 | In distribution |
| NN2338R | Length 1.5 in | 100 | In distribution |
| NN2732R | Length 1.25 in | 100 | In distribution |
| NN2125R | Needle Gauge 21 G | 100 | In distribution |
| NN2613R | Length 0.5 in | 100 | In distribution |
| NN2538R | Length 1.5 in | 100 | In distribution |
| NN2238R | Needle Gauge 22 G | 100 | In distribution |
| NN1925R | Length 1 in | 100 | In distribution |
| NN3013R | Length 0.5 in | 100 | In distribution |
| NN2138R | Length 1.5 in | 100 | In distribution |
| NN2025V | Length 1 in | 100 | In distribution |
| NN2522R | Length 0.87 in | 100 | In distribution |
| NN3025R | Length 1 in | 100 | In distribution |
| NN2038R | Length 1.5 in | 100 | In distribution |
| NN1825R | Length 1 in | 100 | In distribution |
| NN2325R | Needle Gauge 23 G | 100 | In distribution |
| NN2225R | Length 1 in | 100 | In distribution |
| NN2525R | Needle Gauge 25 G | 100 | In distribution |
| NN1838R | Needle Gauge 18 G | 100 | 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 |
|---|---|
| K152362 | 2015-10-16 |
| K121607 | 2012-11-08 |
| K122249 | 2012-08-28 |
| K113422 | 2012-03-05 |
Recalls Naming This Product
9 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 |
|---|---|---|---|---|---|---|---|
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 729,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 444,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 638,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 440,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 844,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 563,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 810,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 30,000 | 2020-05-08 |
| Terumo Corp. | 510(k) number | 2019-02-08 | Class II | Packaging | There is a potential for a loss of package integrity that may compromise the sterility of the product. | 81,000 | 2020-05-08 |
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.