FDA.reportPublic FDA data

Medline

Primary DI
10193489143515
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENFIT332415
Catalog number
ENFIT332415
Device description
BALLOON BUTTON,MEDLINE,ENFIT,24FR,1.5CM
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
10193489143515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348914351510193489143515

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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489143171MedlineMEDLINE INDUSTRIES, INC.PSH2024-07-29
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
10193489143744MedlineMEDLINE INDUSTRIES, INC.PSH2024-03-28