FDA.reportPublic FDA data

Sovea™

Primary DI
10850009501421
Brand
Sovea™
Company
CUTTING EDGE HC BRANDS LLC
Model
ITG-24012
Catalog number
ITG-24012
Device description
"Sovea™ Extension Set, Right Angle Connector, 2 Port ""Y"", 12"" L"
Published
2020-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
30850009501425PackageGS15In Commercial Distribution
50850009501429PackageGS15In Commercial Distribution
10850009501421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085000950142530850009501425
5085000950142950850009501429
1085000950142110850009501421

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
Length12Inch

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071146474MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146481MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146498MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146504MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146535MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146542MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147075MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147082MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147259MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147266MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00842071146337MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146344MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146375MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146382MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146795MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146801MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147136MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147143MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147150MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147167MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20