Device
The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for...
Manufacturer
Safeguard US Operating, LLC
Model: 04 Catalog: 80-100-20 DI: M6898010020040 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Description
The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting and securing a saline lock plus a macro-drip IV administration set.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 6a5ac823-10b3-4e19-a62c-404e459be1b0
Distribution Status: In Commercial Distribution
DUNS Number: 118492643
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: M6898010020040
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 18009
Name: Intraosseous infusion kit
Definition:
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.
FDA Product Codes
LRS
I.V. Start Kit