SolidAIRity Flex 4.1500.2

GUDID 10860009077901

Oral Endotracheal Tube Stabilizer Single Strap, Fits ETT Sizes 7.0mm-8.5mm (I.D.) / 9.3mm-11.8mm (O.D.)

Securisyn Medical, LLC

Endotracheal tube holder

• Primary Device ID: 10860009077901
• NIH Device Record Key: 901e8d7e-e32a-451e-a916-00606d14438e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SolidAIRity Flex
• Version Model Number: 4.1500.2
• Catalog Number: 4.1500.2
• Company DUNS: 067630585
• Company Name: Securisyn Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009077904 [Primary]
GS1	10860009077901 [Package]; Contains: 00860009077904; Package: Box [8 Units]; In Commercial Distribution
HIBCC	B1174150020 [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: 2022-12-12
• Device Publish Date: 2022-12-02

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