FDA.reportPublic FDA data

AVANOS

Primary DI
00350770003078
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
H9386104EN
Catalog number
H9386104EN
Device description
H9386104EN ENFit Bax AdaptaCap Size D
Published
2021-05-13
Public version status
New
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
KYXDISPENSER, LIQUID MEDICATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770003075PackageGS116In Commercial Distribution
00350770003078PrimaryGS10
20350770003072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000307510350770003075
00350770003078003507700030783507700030780350770003078
2035077000307220350770003072

GMDN Terms#

Term, Definition table
TermDefinition
Medicine bottle capA sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
09420060205039haakaaTHINK GREEN LIMITEDKYX2026-09-20
09420060205046haakaaTHINK GREEN LIMITEDKYX2026-09-20
10840330702765ProCureTwin Med, LLCKYX2026-07-08
00827989008175Topi-CLICKHealth Care Logistics, Inc.KYX2026-06-15
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20