ShippertTech 5-IOSS-US

GUDID 00850458007058

The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe.

ACTUATED MEDICAL, INC.

Intraosseous infusion kit

• Primary Device ID: 00850458007058
• NIH Device Record Key: 5216aaeb-d5bd-4d34-8f03-8065fe184b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShippertTech
• Version Model Number: IO Needle Safety Sheath
• Catalog Number: 5-IOSS-US
• Company DUNS: 791379030
• Company Name: ACTUATED MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850458007058 [Primary]
GS1	10850458007055 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

Devices Manufactured by ACTUATED MEDICAL, INC.

• 00850458007058 - ShippertTech: 2023-08-03The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe.
• 00850458007058 - ShippertTech: 2023-08-03 The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraoss
• 00850458007003 - TubeClear: 2021-01-11 TubeClear Clearing Stem for clearing clogs / occlusions in silicone AMT, MIC, and MIC-KEY gastro-jejunostomy tubes size 14-22 Fr
• 20850458007083 - TubeClear: 2018-10-25 TubeClear
• 00850458007010 - TubeClear: 2018-07-06
• 20850458007090 - TubeClear: 2018-07-06 Clearing Stem
• 20850458007106 - TubeClear: 2018-07-06 Clearing Stem
• 20850458007113 - TubeClear: 2018-07-06 Clearing Stem
• 20850458007120 - TubeClear: 2018-07-06 Clearing Stem