FDA.reportPublic FDA data

BIONIX DEVELOPMENT CORPORATION

Primary DI
08599110040072
Brand
BIONIX DEVELOPMENT CORPORATION
Company
M&H Medical Holdings, Inc.
Model
DG-912
Catalog number
912
Device description
DeClogger 16-18 F/Yellow
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
08599110040027PackageGS110Not in Commercial Distribution
08599110040072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08599110040027085991100400278599110040027
08599110040072085991100400728599110040072

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
08599110040065BIONIX DEVELOPMENT CORPORATIONDG-9119112016-10-26
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

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Primary DI, Brand, Company table
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