Sovea™

Basic Information

• Brand Name: Sovea™
• Primary DI: 10850009501360
• Version / Model: ITG-42420
• Catalog Number: ITG-42420
• Company Name: CUTTING EDGE HC BRANDS LLC
• Labeler DUNS: 080216804
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-10
• Public Version: 3
• Public Version Date: 2020-05-11
• Public Version Status: Update
• Public Device Record Key: 18e5e6b0-56d7-4a38-9891-754c23474311

Device Description

Sovea™ Gastrostomy Feeding Tube with Y Ports, 24FR 20ml ENFit Connector, Sterile

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35419	Gastrostomy tube	A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50850009501368	GS1	Carton	6	In Commercial Distribution
Package	30850009501364	GS1	Box	5	In Commercial Distribution
Primary	10850009501360	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092418	000

Device Sizes

Type	Value	Unit	Text
Total Volume	20	Milliliter
Catheter Gauge	24	French