FDA.reportPublic FDA data

Halyard

Primary DI
10885632465031
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
EFGK1617
Device description
Low Profile Gastrostomy Tube/ G Button Kit - 16FRX1.7CM
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNMDEVICE, PRESSURE APPLYING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNMDevice, Pressure ApplyingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632465038PackageGS15In Commercial Distribution
10885632465031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563246503820885632465038
1088563246503110885632465031

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy buttonA sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632524936SurgiTrackSM450087A18C2026-07-09
10885632524943SurgiTrackSM4500872B162026-07-09
10885632524882SurgiTrackSM4500877C312026-07-08
10885632524899SurgiTrackSM45008780392026-07-08
10885632524905SurgiTrackSM45008766152026-07-08
10885632524912SurgiTrackSM45008762622026-07-08
10885632524929SurgiTrackSM450087F5C22026-07-08
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632524790SurgiTrackSM450087D8CD2026-06-25
10885632524721SurgiTrackSM450070DAF72026-06-24
10885632524738SurgiTrackSM450071932C2026-06-24
10885632523267SurgiTrackSM45008746332026-06-10
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547248600020SEIRIN ShonishinSEIRIN CORPORATIONKNM2026-05-31
20885632465038HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
00818318025352iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
10818318029081iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
04547248423056SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
04547248423063SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
14547248423053SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
24547248423067SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
06977182810113Shenzhen Wells Optoelectronics Co.,Ltd.Shenzhen Wells Optoelectronics Co.,Ltd.KNM2024-06-16
03760262490625BAT02 Glass rodsSEDATELECKNM2024-04-25
03760262490670EASYO 1 - Multi Pressure FeelerSEDATELECKNM2024-04-25
03760262492902PAL130 Pressure feeler 130gSEDATELECKNM2024-04-25
03760262492919PAL250 Pressure feeler 250gSEDATELECKNM2024-04-25
03760262492926PAL400 Pressure feeler 400gSEDATELECKNM2024-04-25
03760262492933PAL650 Pressure feeler 650gSEDATELECKNM2024-04-25
07350120791955KIWI DermaForeo ABKNM2024-03-11
06901452150005HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150012HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150029HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150050HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150067HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150074HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150081HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
16901452983860HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
36901452983864HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
00840252904004Sensory VestTherafin CorporationKNM2023-07-06
00840252904011Sensory VestTherafin CorporationKNM2023-07-06
00840252904028Sensory VestTherafin CorporationKNM2023-07-06
00840252904035Sensory VestTherafin CorporationKNM2023-07-06
00840252904042Sensory CuffTherafin CorporationKNM2023-07-06