SolidAIRity Flex 4.1500.3

GUDID B1174150030

Oral Endotracheal Tube Stabilizer, Replacement Neck Straps

Securisyn Medical, LLC

Endotracheal tube holder

• Primary Device ID: B1174150030
• NIH Device Record Key: 6ec63431-a14f-4b9c-9e1b-a0a70a6c18f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SolidAIRity Flex
• Version Model Number: 4.1500.3
• Catalog Number: 4.1500.3
• Company DUNS: 067630585
• Company Name: Securisyn Medical, LLC
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00860009077911 [Unit of Use]
GS1	10860009077918 [Primary]
HIBCC	B1174150030 [Secondary]

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [SolidAIRity Flex]

• 10860009077925: Oral Endotracheal Tube Stabilizer Dual Strap, Fits ETT Sizes 7.0mm-8.5mm (I.D.) / 9.3mm-11.8mm (
• 10860009077901: Oral Endotracheal Tube Stabilizer Single Strap, Fits ETT Sizes 7.0mm-8.5mm (I.D.) / 9.3mm-11.8mm
• B1174150030: Oral Endotracheal Tube Stabilizer, Replacement Neck Straps