FDA UDI
In Commercial Distribution
🇺🇸 United States
OxyMulti-Mask™
DI: 10620974000539
·
Model: OHH-1025-8
·
Southmedic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- OxyMulti-Mask™
- Primary DI
- 10620974000539
- Version / Model
- OHH-1025-8
- Catalog Number
- OHH-1025-8
- Company Name
- Southmedic Incorporated
- Labeler DUNS
- 246848147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6ab8b94c-4e2b-4b39-b049-d4c6b2e6c6bb
Device Description
OXYMULTI MASK W ADAPTER & 7ft TUBING
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 58810 | Vortex oxygen face mask | A non-sterile, form-shaped, fenestrated device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. It incorporates a pin/diffuser intended to create vortices of high-concentration O2 directed to the mouth and nose to provide the full range of FiO2 (fraction of inspired oxygen) required for oxygen therapy. The fenestration designed to prevent positive pressure build-up and rebreathing, also allows for easier communication/feeding. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer) is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10620974000539 | GS1 | ||||
| Unit of Use | 00620974000532 | GS1 |
Customer Contacts
- Phone
- +1(705)726-9383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K760489 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | OXYMULTI MASK W ADAPTER & 7ft TUBING |