AccessGUDID - DEVICE: INTRAVENOUS INFUSION STARTER SET (M68980100120)

GUDID

Device Identifier (DI) Information

Brand Name: INTRAVENOUS INFUSION STARTER SET
Version or Model: 12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-100
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68980100120
Issuing Agency: HIBCC
Commercial Distribution End Date: January 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: 18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea IV Administration Set 1 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea IV Catheter Dressing 1ea Transparent Film Dressing 1 ea Adhesive Bandage 1 ea 2"x2" Gauze Pad (2 pack) 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":	No
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
LRS	I.V. Start Kit

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f57b0e7-de01-457b-bbd8-8bfafd999220
Public Version Date: November 01, 2024
Public Version Number: 2
DI Record Publish Date: October 18, 2022