FDA.reportPublic FDA data

Sovea™

Primary DI
10850009501223
Brand
Sovea™
Company
CUTTING EDGE HC BRANDS LLC
Model
ITG-31620
Catalog number
ITG-31620
Device description
Sovea™ Gastrostomy Feeding Tube with Y Ports, 16FR 20ml, Sterile
Published
2020-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092418000ENTRACARE GASTROSTOMY FEEDING TUBEEntracare, LLC2009-10-23KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850009501227PackageGS15In Commercial Distribution
50850009501221PackageGS16In Commercial Distribution
10850009501223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085000950122730850009501227
5085000950122150850009501221
1085000950122310850009501223

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Total Volume20Milliliter

Contacts#

Phone, Email table
PhoneEmail
323-761-0035info@cuttingedgehc.com

Regulatory Flags#

DUNS number
080216804
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850108006011RespVent™RTG-01000RTG-010002017-10-16
00850108006028RespVent™RTG-01001RTG-010012017-10-16
00850108006035RespVent™RTG-01002RTG-010022017-10-16
00850108006097RespVent™RTG-01100RTG-011002016-09-23
00850108006103RespVent™RTG-01101RTG-011012016-09-23
00850108006042RespVent™RTG-01003RTG-010032022-12-30
00850108006059RespVent™RTG-01004RTG-010042022-12-30
00850108006066RespVent™RTG-01050RTG-010502022-12-30
00850108006073RespVent™RTG-01051RTG-010512022-12-30
00850108006080RespVent™RTG-01052RTG-010522022-12-30
00850108006110Adapt O-Life™RTG-19000RTG-190002022-12-30
00850108006127Trach O-Flex™RTG-19001RTG-190012022-12-30
00850108006134Trach O-Flex™RTG-19002RTG-190022022-12-30
00850108006141RespVac™RTG-02006RTG-020062022-12-30
00850108006158RespVac™RTG-02008RTG-020082022-12-30
00850108006165RespVac™RTG-02010RTG-020102022-12-30
00850108006172RespVac™RTG-02012RTG-020122022-12-30
00850108006189RespVac™RTG-02014RTG-020142022-12-30
00850108006196RespVac™RTG-02016RTG-020162022-12-30
00850108006202RespVac™RTG-02018RTG-020182022-12-30

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