AccessGUDID - DEVICE: T.A.L.O.N. 7-Site I.O. Starter Kit (M6898008100)

GUDID

Device Identifier (DI) Information

Brand Name: T.A.L.O.N. 7-Site I.O. Starter Kit
Version or Model: 80-081
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-081
Company Name: Safeguard US Operating, LLC

Primary DI Number: M6898008100
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device 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

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18009	Intraosseous infusion kit	A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 479a7ae5-05c4-4ec5-a710-b1d3126ce365
Public Version Date: June 30, 2023
Public Version Number: 5
DI Record Publish Date: March 08, 2017