FDA UDI
In Commercial Distribution
🇺🇸 United States
Vortex
DI: 00744229510475
·
Model: 051F8000
·
PARI RESPIRATORY EQUIPMENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vortex
- Primary DI
- 00744229510475
- Version / Model
- 051F8000
- Company Name
- PARI RESPIRATORY EQUIPMENT, INC.
- Labeler DUNS
- 804736098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-26
- Public Version
- 1
- Public Version Date
- 2024-05-06
- Public Version Status
- New
- Public Device Record Key
- 311ae50c-7d43-472e-bac3-c3fd5c4acf3c
Device Description
Vortex Nonelectrostatic Holding Chmbr
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
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38018 | Medicine chamber spacer, reusable | A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00744229510529 | GS1 | carton | 12 | In Commercial Distribution | |
| Primary | 00744229510475 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020944 | 000 |