FDA UDI
In Commercial Distribution
🇺🇸 United States
Adult Aerosol Mask
DI: 00848530060978
·
Model: RES2110
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Adult Aerosol Mask
- Primary DI
- 00848530060978
- Version / Model
- RES2110
- Catalog Number
- RES2110
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-19
- Public Version
- 2
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- be8c4c33-6e52-45e4-999e-824cb1ccced1
Device Description
Adult Aerosol Mask
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYF | Mask, Oxygen, Low Concentration, Venturi | Anesthesiology | 868.5600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35142 | Aerosol face mask, rebreathing, single-use | A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848530060975 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00848530060978 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]