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
Rx
false
OTC
false
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
50192253027646DoverCardinal Health 200, LLCKNY2024-07-10
10192253032338DoverCardinal Health 200, LLCKNY2024-07-10
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
00821925027589VARI-PASS 10/12 Fr (3.3/4mm) x 54CMGyrus Acmi, Inc.KNY2017-05-11
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
03700512983590BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmPromeplaKNY2016-10-03
03700512983606BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmPromeplaKNY2016-10-03
03700512983613BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmPromeplaKNY2016-10-03
00821925035157UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035164UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035171UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035188UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035195UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035201UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035218UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035225UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035256UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035270UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035287UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035294UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035300UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
20884521007816DoverCardinal Health, Inc.KNY2016-09-24
10607915111660Acucise® Endopyelotomy SystemAPPLIED MEDICAL RESOURCES CORPORATIONKNY2016-09-24
04048551086025n.a.Karl Storz GmbH & Co. KGKNY2016-09-23
03700512985587RocaFlex Access Sheath & Dilation Catheter 10/12x35cmPromeplaKNY2016-09-14