SteriGear

Basic Information

• Brand Name: SteriGear
• Primary DI: 00851616002564
• Version / Model: UE4001-00
• Company Name: Sterigear, LLC
• Labeler DUNS: 809509297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-11
• Public Version: 1
• Public Version Date: 2021-05-19
• Public Version Status: New
• Public Device Record Key: 486593b5-6deb-4a8f-93e7-a422eb44e577

Device Description

Twin Fig Leaf 2000ml 10286

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FCN	Urinary drainage collection kit, for indwelling catheter	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851616002561	GS1		20	In Commercial Distribution
Primary	00851616002564	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature