FDA.reportPublic FDA data

Halyard

Primary DI
10680651445787
Brand
Halyard
Company
Avanos Medical, Inc.
Model
44578
Catalog number
8650-18-22
Device description
MIC* Gastric-Jejunal Feeding Tube with ENFit® Connectors (Endoscopic/Radiologic Placement Kit)
Published
2017-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNYACCESSORIES, CATHETER, G-U

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNYAccessories, Catheter, G-UGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10680651445787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068065144578710680651445787

GMDN Terms#

Term, Definition table
TermDefinition
Jejunostomy tubeA sterile, thin, flexible, hollow tube percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00None

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253027648DoverCardinal Health 200, LLCKNY2024-07-10
50192253032336DoverCardinal Health 200, LLCKNY2024-07-10
50192253027646DoverCardinal Health 200, LLCKNY2024-07-10
10192253032338DoverCardinal Health 200, LLCKNY2024-07-10
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
03700512986195Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512986201Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512986218Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512986225Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
00821925036345VARI-PASSGyrus ACMI, LLCKNY2017-05-11
00821925027589VARI-PASS 10/12 Fr (3.3/4mm) x 54CMGyrus Acmi, Inc.KNY2017-05-11
00821925035393UroPassGyrus ACMI, LLCKNY2016-10-12
00821925035409UroPass Gyrus ACMI, LLCKNY2016-10-12
00821925035423UroPassGyrus ACMI, LLCKNY2016-10-12
00821925005976UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005983UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005990UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925035317UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035324GYRUS ACMI, INCGyrus ACMI, LLCKNY2016-10-03
00821925035331UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035348UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035355UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035362UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035379UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035386UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035416UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035430UroPassGyrus ACMI, LLCKNY2016-10-03