FDA.reportPublic FDA data

AVANOS

Primary DI
00350770949321
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
94932
Catalog number
0122-02
Device description
MIC-KEY* Continuous Feed Extension Set with SECUR-LOK*
Published
2020-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K982894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982894000MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITBallard Medical Products1998-09-11KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770949328PackageGS15In Commercial Distribution
00350770949321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077094932810350770949328
00350770949321003507709493213507709493210350770949321

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
Length60Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1095816020630-202026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1095818020630-242026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095822020640-142026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095823020640-202026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095824020640-242026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095828020644-142026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095829020644-202026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095830020644-242026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095832020645-202026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095833020645-242026-10-20
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071121105MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121112MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121129MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121136MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121143MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121150MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121167MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121174MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121181MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121198MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121204MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121211MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121228MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121235MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121242MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121259MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121266MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11