FDA UDI
In Commercial Distribution
🇺🇸 United States
INNOSPIRE GO AUNZ
DI: 00383730004389
·
Model: 00
·
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INNOSPIRE GO AUNZ
- Primary DI
- 00383730004389
- Version / Model
- 00
- Catalog Number
- 1135360
- Company Name
- RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
- Labeler DUNS
- 220018415
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-17
- Public Version
- 1
- Public Version Date
- 2019-06-25
- Public Version Status
- New
- Public Device Record Key
- d8d9bed7-d008-4898-a9c7-ef6bb6746150
Device Description
INNOSPIRE GO AUNZ
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| CAF | NEBULIZER (DIRECT PATIENT INTERFACE) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12719 | Ultrasonic nebulizing system | An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00383730004389 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170853 | 000 |