T.A.L.O.N. 7-Site I.O. Starter Kit 80-081

GUDID M6898008100

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

COMBAT MEDICAL SYSTEMS, LLC

Intraosseous infusion kit

• Primary Device ID: M6898008100
• NIH Device Record Key: 479a7ae5-05c4-4ec5-a710-b1d3126ce365
• Commercial Distribution Discontinuation: 2023-06-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T.A.L.O.N. 7-Site I.O. Starter Kit
• Version Model Number: 80-081
• Catalog Number: 80-081
• Company DUNS: 809773968
• Company Name: COMBAT MEDICAL SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedicalsystems.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M6898008100 [Primary]

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-06
• Device Publish Date: 2017-03-08

On-Brand Devices [T.A.L.O.N. 7-Site I.O. Starter Kit]

• M6898008100: The T.A.L.O.N.™ (Tactically Advanced Lifesaving IO Needle) is the single solution for intraoss
• M68980081030: T.A.L.O.N. 7-Site I.O. Starter Set T.A.L.O.N. IO Needle Set 1 ea EZ-Stabilizer