SolidAIRity Flex

Basic Information

• Brand Name: SolidAIRity Flex
• Primary DI: 00860009077904
• Version / Model: 4.1500.2
• Catalog Number: 4.1500.2
• Company Name: Securisyn Medical, LLC
• Labeler DUNS: 067630585
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 901e8d7e-e32a-451e-a916-00606d14438e

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	868.5770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35815	Endotracheal tube holder	A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860009077901	GS1	Box	8	In Commercial Distribution
Primary	00860009077904	GS1
Secondary	B1174150020	HIBCC