Sovea™ ITG-42020

GUDID 50850009501344

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

CUTTING EDGE HC BRANDS LLC

Gastrostomy tube
Primary Device ID50850009501344
NIH Device Record Key6dbebe24-a51b-4f3c-8eb6-b926bf5858f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSovea™
Version Model NumberITG-42020
Catalog NumberITG-42020
Company DUNS080216804
Company NameCUTTING EDGE HC BRANDS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone323-761-0035
Emailinfo@cuttingedgehc.com

Device Dimensions

Catheter Gauge20 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110850009501346 [Primary]
GS130850009501340 [Package]
Contains: 10850009501346
Package: Box [5 Units]
In Commercial Distribution
GS150850009501344 [Package]
Contains: 30850009501340
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-11
Device Publish Date2020-02-10

On-Brand Devices [Sovea™]

50850009501368Sovea™ Gastrostomy Feeding Tube with Y Ports, 24FR 20ml ENFit Connector, Sterile
50850009501351Sovea™ Gastrostomy Feeding Tube with Y Ports, 22FR 20ml ENFit Connector, Sterile
50850009501344Sovea™ Gastrostomy Feeding Tube with Y Ports, 20FR 20ml ENFit Connector, Sterile
50850009501337Sovea™ Gastrostomy Feeding Tube with Y Ports, 18FR 20ml ENFit Connector, Sterile
50850009501320Sovea™ Gastrostomy Feeding Tube with Y Ports, 16FR 20ml ENFit Connector, Sterile
50850009501313Sovea™ Gastrostomy Feeding Tube with Y Ports, 14FR 20ml ENFit Connector, Sterile
50850009501306Sovea™ Gastrostomy Feeding Tube with Y Ports, 20FR 10ml ENFit Connector, Sterile
50850009501290Sovea™ Gastrostomy Feeding Tube with Y Ports, 16FR 10ml ENFit Connector, Sterile
50850009501283Sovea™ Gastrostomy Feeding Tube with Y Ports, 14FR 10ml ENFit Connector, Sterile
50850009501276Sovea™ Gastrostomy Feeding Tube with Y Ports, 12FR 10ml ENFit Connector, Sterile
50850009501269Sovea™ Gastrostomy Feeding Tube with Y Ports, 24FR 20ml, Sterile
50850009501252Sovea™ Gastrostomy Feeding Tube with Y Ports, 22FR 20ml, Sterile
50850009501245Sovea™ Gastrostomy Feeding Tube with Y Ports, 20FR 20ml, Sterile
50850009501238Sovea™ Gastrostomy Feeding Tube with Y Ports, 18FR 20ml, Sterile
50850009501221Sovea™ Gastrostomy Feeding Tube with Y Ports, 16FR 20ml, Sterile
50850009501214Sovea™ Gastrostomy Feeding Tube with Y Ports, 14FR 20ml, Sterile
50850009501207Sovea™ Gastrostomy Feeding Tube with Y Ports, 20FR 10ml, Sterile
10850009501193Sovea™ Gastrostomy Feeding Tube with Y Ports, 16FR 10ml, Sterile
50850009501184Sovea™ Gastrostomy Feeding Tube with Y Ports, 14FR 10ml, Sterile
50850009501177Sovea™ Gastrostomy Feeding Tube with Y Ports, 12FR 10ml, Sterile
30850009501425Sovea™ Extension Set, Right Angle Connector, 2 Port "Y", 12" L
30850009501418Sovea™ Extension Set, Right Angle Connector, 2 Port "Y", 24" L
30850009501401Sovea™ Extension Set, Right Angle Connector, 24"
30850009501395Sovea™ Extension Set, Straight Connector, 24"
30850009501388Sovea™ Extension Set, Right Angle Connector, 12"
30850009501371Sovea™ Extension Set, Straight Connector, 12"
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.