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

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• 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

• 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