FDA.reportPublic FDA data

NEOMED*

Primary DI
10350770000449
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
PC-GNC
Catalog number
PC-GNC
Device description
ENFit Pharm Cap Size G NonSterile Purp
Published
2021-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10350770000449PackageGS116In Commercial Distribution
00350770000442PrimaryGS10
20350770000446Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000044910350770000449
00350770000442003507700004423507700004420350770000442
2035077000044620350770000446

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193494001695PROBLOC* II Insulated Regional Block Needle120008760HN3S-1002025-12-08
10193494001701PROBLOC* II Insulated Regional Block Needle120008761HN3S-1502025-12-08
10193494001718PROBLOC* II Insulated Regional Block Needle120008762HN3S-402025-12-08
10193494001725PROBLOC* II Insulated Regional Block Needle120008763HN3S-802025-12-08
10193494001732PROBLOC* II Insulated Regional block Needle120008753HN1-402025-11-28
10193494001749PROBLOC* II Insulated Regional block Needle120008754HN1-802025-11-28
10193494001756PROBLOC* II Insulated Regional block Needle120008755HN2-402025-11-28
10193494001763PROBLOC* II Insulated Regional block Needle120008756HN2-802025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating Cable120008759EBL18100TGC2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008740EBL20100SG2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008741EBL20100SGC2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008742EBL20150SG2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008743EBL20150SGC2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008744EBL22050SG2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection Set120008745EBL22050SGC2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008746ELL18050SGC2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008747ELL18050TG2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008748ELL18050TGC2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008749ELL18100SGC2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008750ELL18100TG2025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360023639DoselogixTEAM TECHNOLOGIES, INC.KYX2026-03-24
80827989007853Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007846Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007860Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007877Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007884Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007891Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
00810126506351Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506368Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506375Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506382Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506399Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506405Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506412Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506429Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506436Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506443Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506450Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00194346098088EquateWAL-MART STORES, INC.KYX2025-11-14
04046955861132Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861170Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861217Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
10810080612492OptiDropper®, SafeFill™MPS Pharma & Medical, Inc.KYX2025-08-19
10810080612485OptiDropper®MPS Pharma & Medical, Inc.KYX2025-08-15
00813360023189DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023196DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023202DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023219DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
10810080612461OptiDropper®MPS Pharma & Medical, Inc.KYX2025-07-19
00813360023240DoselogixTEAM TECHNOLOGIES, INC.KYX2025-06-05