FDA.reportPublic FDA data

Medline

Primary DI
27290110061443
Brand
Medline
Company
DEGANIA SILICONE LTD
Model
103310011489MD
Device description
Gastrostomy Button G1I 0.8cm 14Fr ENFit Big Blis
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
27290110061443PackageGS11In Commercial Distribution
47290110061447PackageGS15In Commercial Distribution
07290110061449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729011006144327290110061443
4729011006144747290110061447
07290110061449072901100614497290110061449

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy buttonA sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600007082
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
10884522000017Covidien AG90051T2025-04-03
30884522000028Covidien AG90052T2025-04-03
30884522000035Covidien AG90053T2025-04-03
30884522000042Covidien AG90054T2025-04-03
30884522000059Covidien AG90055T2025-04-03
30884522000066Covidien AG90056T2025-04-03
20884522000014Covidien AG90051T2025-04-03
10884522000024Covidien AG90052T2025-04-03
10884522000031Covidien AG90053T2025-04-03
10884522000048Covidien AG90054T2025-04-03
10884522000055Covidien AG90055T2025-04-03
10884522000062Covidien AG90056T2025-04-03
07290110066512Covidien AG102201101680TY2025-03-04
27290110066516Covidien AG102201101680TY2025-03-04
07290110066475Covidien AG102201100880TY2025-02-20
07290110066482Covidien AG102201101080TY2025-02-20
07290110066499Covidien AG102201101280TY2025-02-20
07290110066505Covidien AG102201101480TY2025-02-20
07290110066529Covidien AG102201101880TY2025-02-20
27290110066479Covidien AG102201100880TY2025-02-20

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