FDA.reportPublic FDA data

AVANOS

Primary DI
00350770987033
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
98703
Catalog number
98703
Device description
Enteral Access Dilation System
Published
2020-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGCTUBE, GASTRO-ENTEROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGCTube, Gastro-EnterostomyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093312000KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEMKimberly-Clark Corp.2009-12-08KGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00350770987033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770987033003507709870333507709870330350770987033

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.

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850026037170PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00850026037203PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
10850026037200PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
20850026037177PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00842071148935GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-04-07
00842071148973GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071149000GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071147297GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-11-27
00850026037234PUMA-G System™Coaptech, Inc.KGC2024-10-29
00860312001559PUMA-G System™Coaptech, Inc.KGC2024-10-29
10850026037231PUMA-G System™Coaptech, Inc.KGC2024-10-29
10860312001556PUMA-G System™Coaptech, Inc.KGC2024-10-29
00842071144968GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
00842071144999GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
10860312001532PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037333PUMA-G System™Coaptech, Inc.KGC2024-05-16
10850026037330PUMA-G System™Coaptech, Inc.KGC2024-05-16
00860312001542PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037319PUMA-G System™Coaptech, Inc.KGC2024-05-09
00850026037227PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037272PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037029PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037050PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037098PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037074PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037043PUMA-G System™Coaptech, Inc.KGC2023-07-13
00860312001504PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037036PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037081PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037187PUMA-G System™Coaptech, Inc.KGC2023-07-13