FDA.reportPublic FDA data

BIONIX DEVELOPMENT CORPORATION

Primary DI
08599110040065
Brand
BIONIX DEVELOPMENT CORPORATION
Company
M&H Medical Holdings, Inc.
Model
DG-911
Catalog number
911
Device description
DeClogger 14-16 F/Blue
Published
2016-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905164000TUBE DECLOGGERNova Design Technologies, Ltd.1991-02-13KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08599110040010PackageGS110Not in Commercial Distribution
08599110040065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08599110040010085991100400108599110040010
08599110040065085991100400658599110040065

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic cough stimulation systemAn assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency (e.g., unconscious, comatose, anaesthetized, obtunded) or the very young/elderly, to help clear the lungs of secretions and aspirated materials (e.g., inhaled fluids or vomitus). It typically consists of: 1) a mains electricity (AC-powered) generator that produces amplified pulsed electrical signals; 2) a handpiece with ultrasonic transducers that convert the electrical signals to ultrasound for external application to the patient?s pharynx via disposable gel pads, to elicit cough reflex; and 3) a connecting cable.

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096xxx@xxx.xxx

Regulatory Flags#

DUNS number
602736795
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08599110040133BIONIX DEVELOPMENT CORPORATIONNP-110011002016-10-25
08599110040140BIONIX DEVELOPMENT CORPORATIONNP-110511052016-10-25
08599110040072BIONIX DEVELOPMENT CORPORATIONDG-9129122016-10-26
08599110040089BIONIX DEVELOPMENT CORPORATIONDG-9139132016-10-26
08599110040096BIONIX DEVELOPMENT CORPORATIONDG-9219212016-10-26
08599110040102BIONIX DEVELOPMENT CORPORATIONDG-9229222016-10-26
08599110040010BIONIX DEVELOPMENT CORPORATIONDG-9119112016-10-26
08599110040027BIONIX DEVELOPMENT CORPORATIONDG-9129122016-10-26
08599110040034BIONIX DEVELOPMENT CORPORATIONDG-9139132016-10-26
08599110040041BIONIX DEVELOPMENT CORPORATIONDG-9219212016-10-26
08599110040058BIONIX DEVELOPMENT CORPORATIONDG-9229222016-10-26
08599110040119BIONIX DEVELOPMENT CORPORATIONNP-110011002016-10-25
08599110040126BIONIX DEVELOPMENT CORPORATIONNP-110511052016-10-25
00859911004917BIONIX DEVELOPMENT CORPORATIONGF-0951095102019-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01