Medline

Primary DI
10193489143157
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENFIT331640
Catalog number
ENFIT331640
Device description
BALLOON BUTTON,MEDLINE,ENFIT,16FR,4.0CM
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
10193489143157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348914315710193489143157

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

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