FDA.reportPublic FDA data

BIONIX DEVELOPMENT CORPORATION

Primary DI
08599110040041
Brand
BIONIX DEVELOPMENT CORPORATION
Company
M&H Medical Holdings, Inc.
Model
DG-921
Catalog number
921
Device description
DeClogger 14-16 F/Brown
Published
2016-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08599110040041PackageGS110Not in Commercial Distribution
08599110040096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08599110040041085991100400418599110040041
08599110040096085991100400968599110040096

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
602736795
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
08599110040133BIONIX DEVELOPMENT CORPORATIONNP-110011002016-10-25
08599110040140BIONIX DEVELOPMENT CORPORATIONNP-110511052016-10-25
08599110040065BIONIX DEVELOPMENT CORPORATIONDG-9119112016-10-26
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
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
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00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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