FORWARD IO INFUSION KIT

GUDID 00850056748018

FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.

Integrated Medcraft LLC

Intraosseous infusion kit

• Primary Device ID: 00850056748018
• NIH Device Record Key: 3ffc51c7-9f06-4af0-b4a7-2359ecc3632f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORWARD IO INFUSION KIT
• Version Model Number: 1011-23000CB
• Company DUNS: 107523667
• Company Name: Integrated Medcraft LLC
• 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	00850056748018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191488

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-31
• Device Publish Date: 2024-01-23

Devices Manufactured by Integrated Medcraft LLC

• 00850056748063 - FORWARD Gunshot Wound Kit: 2024-10-14 Gun Shot Wound Kit (Includes Cat TQ, Battle Bandage, Halo Vented Chest Seal, Compressed Gauze, and a pre-lubed NPA.)
• 00850056748070 - FORWARD Enforcement Group Medical Bag: 2024-10-14 ATF Enforcement Group Medical Bag (Contains first aid supplies that include N95 mask, CAT Tq, Halo Vented Chest Seals, Battle Ba
• 00850056748001 - FORWARD AAJT-S Deployment Kit: 2024-02-20 FORWARD AAJT-S Deployment Kit includes AAJT-S Junctional Tourniquet and Carry Pouch.
• 00850056748018 - FORWARD IO INFUSION KIT: 2024-01-31FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
• 00850056748018 - FORWARD IO INFUSION KIT: 2024-01-31 FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
• 00850056748025 - FORWARD Field Intubation Kit 7.5: 2024-01-31 IO Field Intubation Kit 7.5 including Endotracheal Tube and Syringe
• 00850056748032 - FORWARD Field Intubation Kit 8.0: 2024-01-31 FORWARD Field Intubation Kit 8.0 including Endotracheal Tube and Syringe