AccessGUDID - DEVICE: Sovea™ (10850009501346)

GUDID

Device Identifier (DI) Information

Brand Name: Sovea™
Version or Model: ITG-42020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITG-42020
Company Name: CUTTING EDGE HC BRANDS LLC

Primary DI Number: 10850009501346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080216804 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092418	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter
Catheter Gauge: 20 French

Device Record Status

Public Device Record Key: 6dbebe24-a51b-4f3c-8eb6-b926bf5858f1
Public Version Date: May 11, 2020
Public Version Number: 3
DI Record Publish Date: February 10, 2020