FDA.reportPublic FDA data

Orange DeClogger®

Primary DI
00859911004269
Brand
Orange DeClogger®
Company
Bionix, LLC
Model
922
Catalog number
922
Device description
Orange DeClogger®
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00859911004269PackageGS110In Commercial Distribution
10859911004266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004269008599110042698599110042690859911004269
1085991100426610859911004266

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
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
10
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911004184Bionix Development Corporation370037002017-01-28
00859911004498Safe Ear Curette™ Variety Kit577757772021-12-10
00859911004429Green MicroLoop®122212222021-12-10
00859911004436Orange ControLoop®299929992021-12-10
00859911004443Red AngleLoop®344434442021-12-10
00859911004450Purple VersaLoop®411141112021-12-10
00859911004467Blue InfantScoop®488848882021-12-10
00859911004474Yellow CeraSpoon®633363332021-12-10
00859911004481White FlexLoop®955595552021-12-10
00859911004528Lighted AngleLoop®221022102021-12-10
00859911004535Lighted MicroLoop®222022202021-12-10
00859911004542Lighted WaveCurette™223022302021-12-10
00859911004559Lighted FlexLoop®224022402021-12-10
00859911004566Lighted Ear Curette™ Variety Pack224522452021-12-10
00859911004573Lighted CeraSpoon®225022502021-12-10
00859911004580Lighted InfantScoop®226022602021-12-10
00859911004597Lighted VersaLoop®227022702021-12-10
00859911004603Lighted CeraPik™228022802021-12-10
00859911004702Lighted Forceps for Foreign Body Removal275027502021-12-10
00859911004726Lighted Placement Tool285028502022-08-08

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