FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIONIX DEVELOPMENT CORPORATION
DI: 08599110040096
·
Model: DG-921
·
M&H Medical Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIONIX DEVELOPMENT CORPORATION
- Primary DI
- 08599110040096
- Version / Model
- DG-921
- Catalog Number
- 921
- Company Name
- M&H Medical Holdings, Inc.
- Labeler DUNS
- 602736795
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-26
- Public Version
- 4
- Public Version Date
- 2023-07-10
- Public Version Status
- Update
- Public Device Record Key
- 992d56c2-a6df-42af-a886-1014b36e8289
- Distribution End Date
- 2017-02-01
Device Description
DeClogger 14-16 F/Brown
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59068 | Ultrasonic cough stimulation system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08599110040041 | GS1 | box | 10 | Not in Commercial Distribution | 2017-02-01 |
| Primary | 08599110040096 | GS1 |
Customer Contacts
- Phone
- +1(800)551-7096
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905164 | 000 |