FDA.reportPublic FDA data

Medline

Primary DI
10193489143614
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENFIT332450
Catalog number
ENFIT332450
Device description
BALLOON BUTTON,MEDLINE,ENFIT,24FR,5.0CM
Published
2024-04-11
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
10193489143614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348914361410193489143614

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
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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
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
10193489143744MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28