FORWARD Field Intubation Kit 8.0

GUDID 00850056748032

FORWARD Field Intubation Kit 8.0 including Endotracheal Tube and Syringe

Integrated Medcraft LLC

Basic endotracheal tube, single-use

• Primary Device ID: 00850056748032
• NIH Device Record Key: 4c4b900c-e2cf-4b43-99de-9b1b78715bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORWARD Field Intubation Kit 8.0
• Version Model Number: 1011-40001
• 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	00850056748032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955495

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

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

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• 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: 2024-01-31 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: 2024-01-31FORWARD Field Intubation Kit 8.0 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