FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 00607411943744
·
Model: HYB551
·
SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- N/A
- Primary DI
- 00607411943744
- Version / Model
- HYB551
- Catalog Number
- HYB51
- Company Name
- SALTER LABS
- Labeler DUNS
- 022721133
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-03
- Public Version
- 5
- Public Version Date
- 2025-02-28
- Public Version Status
- Update
- Public Device Record Key
- dac81a42-0880-4514-bf9f-e55fec9a6c1e
- Distribution End Date
- 2025-02-28
Device Description
Hybrid AV Face Mask – SM, pack of 5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57816 | CPAP/BPAP oral mask | A flexible, form-shaped device designed to be fitted to the user's mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the patient's mouth; this providing a solution for mouth breathers and patients with chronic nasal obstruction. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607411943741 | GS1 | 15 | Not in Commercial Distribution | 2025-02-28 | |
| Primary | 00607411943744 | GS1 |
Customer Contacts
- Phone
- +1(800)421-0024
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062224 | 000 |