FDA.reportPublic FDA data

Medline

Primary DI
10193489142976
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENFIT331435
Catalog number
ENFIT331435
Device description
BALLOON BUTTON,MEDLINE,ENFIT,14FR,3.5CM
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSHPercutaneous replacement gastrostomy tube kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSHPercutaneous Replacement Gastrostomy Tube KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489142976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348914297610193489142976

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tube kit, non-medicatedA collection of devices which includes a gastrostomy tube and other instruments intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy; it does not include any pharmaceutical agents. In addition to the gastrostomy tube, the kit includes additional invasive devices designed to perform the gastrostomy and/or assist tube introduction (e.g., scalpel, introduction needle, stoma sizer, guidewire, dilator). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489143171MedlineMEDLINE INDUSTRIES, INC.PSH2024-07-29
10193489143515MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143522MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143539MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143546MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143553MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143560MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143577MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143584MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143591MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143607MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143614MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-11
10193489143409MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143416MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143423MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143430MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143447MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143454MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143461MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143478MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143485MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143492MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143508MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143836MedlineMEDLINE INDUSTRIES, INC.PSH2024-04-03
10193489143683MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28
10193489143690MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28
10193489143706MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28
10193489143713MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28
10193489143720MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28
10193489143737MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28