FDA.reportPublic FDA data

Bard Button Replacement Gastrostomy Device

Primary DI
10801741087841
Brand
Bard Button Replacement Gastrostomy Device
Company
Bard Access Systems, Inc.
Model
000263
Catalog number
000263
Device description
Button Kit
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10801741087841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080174108784110801741087841

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French
Length4.3Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00801741036712Groshong771070077107002015-09-24
00801741036729Groshong771155077115502015-09-24
00801741037696Groshong772495077249502015-09-24
00801741037719Groshong774155077415502015-09-24
10801741239356PowerPICC Sherlock 3CGCK001067ACK001067A2026-03-11
10801741239363PowerPICC ProvenaCK001068ACK001068A2026-03-11
10801741239370PowerPICC ProvenaCK001069ACK001069A2026-03-11
10801741239271MiniLocCPA00072CPA000722026-02-26
10801741238830PowerPICC Provena SOLOCK001091CK0010912026-02-11
00801741038464Niagara Slim-Cath catheter543215054321502015-12-04
00801741038471Niagara Slim-Cath Catheter543220054322002015-11-20
00801741038488Niagara Slim-Cath catheter543224054322402015-12-04
00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850026037200PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
20850026037177PUMA-G Pediatric System™Coaptech, Inc.KGC2025-12-23
10850026037231PUMA-G System™Coaptech, Inc.KGC2024-10-29
10860312001556PUMA-G System™Coaptech, Inc.KGC2024-10-29
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
00850026037098PUMA-G System™Coaptech, Inc.KGC2023-12-15
00850026037074PUMA-G System™Coaptech, Inc.KGC2023-12-15
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
10850026037132PUMA-G System™Coaptech, Inc.KGC2023-07-13
00842071131777Decompression TubeAPPLIED MEDICAL TECHNOLOGY, INC.KGC2023-06-30
00842071131463Decompression TubeAPPLIED MEDICAL TECHNOLOGY, INC.KGC2023-06-30
00842071131814Decompression TubeAPPLIED MEDICAL TECHNOLOGY, INC.KGC2023-06-30
00842071131838Decompression TubeAPPLIED MEDICAL TECHNOLOGY, INC.KGC2023-06-30
00842071131852Decompression TubeAPPLIED MEDICAL TECHNOLOGY, INC.KGC2023-06-30
00842071131180ATLAS Suture Delivery SystemAPPLIED MEDICAL TECHNOLOGY, INC.KGC2021-11-15
00842071131203ATLAS Suture Delivery SystemAPPLIED MEDICAL TECHNOLOGY, INC.KGC2021-11-15
07290018632017Low Profile Enteral Feeding Device Kit FIDMI MEDICAL LTDKGC2021-08-15
07290018632024Low Profile Enteral Feeding Device Kit FIDMI MEDICAL LTDKGC2021-08-15
07290018632031Low Profile Enteral Feeding Device Kit FIDMI MEDICAL LTDKGC2021-08-15
07290018632048Low Profile Enteral Feeding Device KitFIDMI MEDICAL LTDKGC2021-08-15
07290018632055Low Profile Enteral Feeding Device Kit FIDMI MEDICAL LTDKGC2021-08-15
00350770102269AVANOSAvanos Medical, Inc.KGC2020-05-23
00350770102290AVANOSAvanos Medical, Inc.KGC2020-05-23