FDA UDI
In Commercial Distribution
🇺🇸 United States
Innospire Essence
DI: 00383730004037
·
Model: 1128182
·
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Innospire Essence
- Primary DI
- 00383730004037
- Version / Model
- 1128182
- Catalog Number
- 1128182
- 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
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 307d9242-066a-426d-a523-4a6e685d9187
Device Description
INNOSPIRE ESSENCE COMPRESSOR NEBULIZER SYSTEM, CUSTOM FOR FOCUS HOME MED
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
- 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 |
|---|---|---|---|---|
| BTI | Compressor, air, portable | Anesthesiology | 868.6250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35457 | Benchtop nebulizer, non-heated | An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00383730004037 | GS1 |
Customer Contacts
- Phone
- +1(724)744-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042655 | 000 |