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

• 00850056748094 - Forward Medical Emergency First Aid Kit (ME-FAK): 2025-03-07 First aid box with basic trauma treatment items. Including Tourniquet, Trauma dressing, Compressed Gauze, Chest Seal, Emergenc
• 00850056748100 - Forward Medical Emergency First Aid Kit Plus (ME-FAK Plus): 2025-03-07 First aid box that contains the following items; Tourniquet, Trauma Dressing, Compressed Gauze, Quik Clot Bleeding Control Dress
• 00850056748131 - Forward Tac-FAK Essentials: 2025-03-07 IFAK Kit in Molle Pouch that contains the following contents, Tourniquet, Trauma Dressing, Compressed Gauze, Chest Seal with Ven
• 00850056748148 - Forward Tac-FAK Massive Hemorrhage (Tac-FAK M): 2025-03-07 IFAK Kit in Molle Pouch that contains the following contents, Tourniquet, Trauma Dressing, Quik Clot Combat Gauze, Compressed Ga
• 00850056748155 - Forward Tac-FAK Massive Hemorrhage / Airway (Tac-FAK MA): 2025-03-07 IFAK Kit in Molle Pouch that contains the following contents, Tourniquet, Quik Clot Combat Gauze, Trauma Dressing, Compressed Ga
• 00850056748193 - Forward Opioid Overdose Kit: 2025-02-26 Qty 2 NALOXONE HCL Nasal Spray 4mg/dose. Manufactured by Padagis, Qty 1 CPR Face Shield and a carry case.
• 00850056748087 - FORWARD Active Shooter Aid Pack: 2025-01-07 Kit containing Individual First Aid Kit Supplies including tourniquets, trauma dressings, compressed gauze, Celox, and Nasal Air
• 00850056748162 - FORWARD Crowd First Aid Kit (C-FAK): 2025-01-07 Kit containing Individual First Aid Kit Supplies including tourniquets, trauma dressings, compressed gauze, QuikClot, and gloves