FDA.reportPublic FDA data

Low Profile Enteral Feeding Device Kit

Primary DI
07290018632017
Brand
Low Profile Enteral Feeding Device Kit
Company
FIDMI MEDICAL LTD
Model
FG-20F- ORANGE
Catalog number
FG-20F- ORANGE
Device description
The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement.
Published
2021-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGCTube, Gastro-Enterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGCTube, Gastro-EnterostomyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018632017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018632017072900186320177290018632017

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
600363369
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018632116Replaceable Inner Tubes FG-20F-ORANGE-REPFG-20F-ORANGE-REP2021-08-15
07290018632123Replaceable Inner Tubes FG-20F-PINK-REPFG-20F-PINK-REP2021-08-15
07290018632130Replaceable Inner Tubes FG-20F-BLUE-REPFG-20F-BLUE-REP2021-08-15
07290018632147Replaceable Inner Tubes FG-20F-GREEN-REPFG-20F-GREEN-REP2021-08-15
07290018632000Fidmi Low Profile Percutaneous Endoscopic Measuring KitFG-MESFG-MES2021-08-15
07290018632024Low Profile Enteral Feeding Device Kit FG-20F-PINKFG-20F-PINK2021-08-15
07290018632031Low Profile Enteral Feeding Device Kit FG-20F-BLUEFG-20F-BLUE2021-08-15
07290018632048Low Profile Enteral Feeding Device KitFG-20F-GREENFG-20F-GREEN2021-08-15
07290018632055Low Profile Enteral Feeding Device Kit FG-20F-YELLOWFG-20F-YELLOW2021-08-15
17290018632113Replaceable Inner Tubes FG-20F-ORANGE-REPFG-20F-ORANGE-REP2021-08-15
17290018632120Replaceable Inner Tubes FG-20F-PINK-REPFG-20F-PINK-REP2021-08-15
17290018632137Replaceable Inner Tubes FG-20F-BLUE-REPFG-20F-BLUE-REP2021-08-15
17290018632144Replaceable Inner Tubes FG-20F-GREEN-REPFG-20F-GREEN-REP2021-08-15
07290018632154Replaceable Inner Tubes FG-20F-YELLOW-REPFG-20F-YELLOW-REP2021-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850026037170PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00850026037203PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
10850026037200PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
20850026037177PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
00842071148935GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-04-07
00842071148973GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071149000GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2025-03-07
00842071147297GEMINI Suture LoopAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-11-27
00850026037234PUMA-G System™Coaptech, Inc.KGC2024-10-29
00860312001559PUMA-G System™Coaptech, Inc.KGC2024-10-29
10850026037231PUMA-G System™Coaptech, Inc.KGC2024-10-29
10860312001556PUMA-G System™Coaptech, Inc.KGC2024-10-29
00842071144968GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
00842071144999GEMINIAPPLIED MEDICAL TECHNOLOGY, INC.KGC2024-10-04
10860312001532PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037333PUMA-G System™Coaptech, Inc.KGC2024-05-16
10850026037330PUMA-G System™Coaptech, Inc.KGC2024-05-16
00860312001542PUMA-G System™Coaptech, Inc.KGC2024-05-16
00850026037319PUMA-G System™Coaptech, Inc.KGC2024-05-09
00850026037227PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037272PUMA-G System™Coaptech, Inc.KGC2024-02-13
00850026037029PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037050PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037098PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037074PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037043PUMA-G System™Coaptech, Inc.KGC2023-07-13
00860312001504PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037036PUMA-G System™Coaptech, Inc.KGC2023-07-13
00850026037081PUMA-G System™Coaptech, Inc.KGC2023-07-13
10850026037187PUMA-G System™Coaptech, Inc.KGC2023-07-13