PouchPro

Basic Information

• Brand Name: PouchPro
• Primary DI: 00714646000026
• Version / Model: 5040
• Catalog Number: 5040
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-08-08
• Public Version: 3
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: b9db2125-375a-40c2-99f1-82ebc1c93045

Device Description

SecureFoam - Pouch-Pro, Medium, Box Label

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
IYE	Accelerator, linear, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40902	Radiological whole-body positioner	A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10714646000023	GS1
Primary	00714646000026	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040773	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 65 – 95 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry environment. Do not expose to open flame or tempera- tures over 95 degrees Fahrenheit. Excessive heat can cause premature aging of components, resulting in a shorter shelf life.