FDA.reportPublic FDA data

AVANOS

Primary DI
00350770949437
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
94943
Catalog number
0126-12
Device description
MIC-KEY* Threaded Extension Set with SECUR-LOK*
Published
2020-04-27
Public version status
Update
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
10350770949434PackageGS15In Commercial Distribution
00350770949437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077094943410350770949434
00350770949437003507709494373507709494370350770949437

GMDN Terms#

Term, Definition table
TermDefinition
Enteral tube extension, single-useA thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube, gastrostomy tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

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