AccessGUDID - DEVICE: T.A.L.O.N. 7-Site I.O. Starter Kit (M68980081030)

GUDID

Device Identifier (DI) Information

Brand Name: T.A.L.O.N. 7-Site I.O. Starter Kit
Version or Model: 03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-081
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68980081030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: T.A.L.O.N. 7-Site I.O. Starter Set T.A.L.O.N. IO Needle Set 1 ea EZ-Stabilizer 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 2 ea Alcohol Prep Pad 2 ea T.A.L.O.N. IFU 1 ea EZ-Stabilizer IFU 1 ea

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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: bcc60824-96ba-4297-a12b-b283bfee6cda
Public Version Date: April 12, 2022
Public Version Number: 2
DI Record Publish Date: April 03, 2020