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

FDA UDI

Class II (US FDA UDI)

by Safeguard Us Operating, Llc

Identity

Trade Name: T.A.L.O.N. 7-Site I.O. Starter Kit FDA UDI
Generic Name: Intraosseous infusion kit FDA UDI
Device Name: 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 FDA UDI
Model / Reference: 80-081 FDA UDI
Description: 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 FDA UDI

Identifiers

Catalog Number: 80-081 FDA UDI
Primary DI / UDI-DI: M6898008100 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Intraosseous infusion kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

T.A.L.O.N. 7-Site I.O. Starter Kit by Safeguard Us Operating, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Safeguard Us Operating, Llc

Sources (1)

FDA UDI 479a7ae5-05c4-4ec5-a710-b1d3126ce365 37 fields · synced May 30, 2026