T.a.l.o.n. 7-Site I.O. Starter Kit
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous vascular access. The T.A.L.O.N.™ provides combat lifesavers and combat medics with rapid…
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous vascular access. The T.A.L.O.N.™ provides combat lifesavers and combat medics with rapid and accurate, manual IO access to all seven sites. Product Description The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraosseous (IO) vascular access. The T.A.L.O.N. allows providers rapid and accurate IO access to all seven sites. The T.A.L.O.N. delivers life-saving fluids and medications rapidly and accurately for casualty resuscitation. T.A.L.O.N. is the first and only FDA-cleared manual IO device with 7-site access: sternum, bilateral proximal humerus, bilateral proximal tibia, and bilateral distal tibia. A single T.A.L.O.N. provides IO access → there are no powered tools or multiple needles necessary and no special removal tool is required. Simple step-by-step instructions and minimal insertion pressure is required to ensure that combat lifesavers and medics can use the T.A.L.O.N. effectively with proper training. Capabilities • 7-Site IO Vascular Access • Simple Delivery of life-saving fluids and medication • Rapid Resuscitation Product Attributes • Access to any IO site with one manual device • No need for additional devices, multiple needles or special removal tools • Meets CoTCCC recommendations for IO devices Clinical Benefits • First and only FDA-cleared manual IO device with 7-site access: o Sternum o Bilateral proximal humerus o Bilateral proximal tibia o Bilateral distal tibia • Delivers fluids and medications rapidly and safely
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 | Safeguard US Operating, LLC, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2018-08-09 |
| Record revised | 2023-06-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool dry place |
| Distribution end date | 2025-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03 | In distribution | |
| 00 | Withdrawn | |
| 80-081 | Withdrawn |
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
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.