FDA UDI
In Commercial Distribution
🇺🇸 United States
Therapy Mask 3100
DI: 00606959060128
·
Model: Large, Therapy Mask 3100 Silicone Pillow
·
Respironics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Therapy Mask 3100
- Primary DI
- 00606959060128
- Version / Model
- Large, Therapy Mask 3100 Silicone Pillow
- Catalog Number
- 1145058
- Company Name
- Respironics, Inc.
- Labeler DUNS
- 080728314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-27
- Public Version
- 1
- Public Version Date
- 2021-11-04
- Public Version Status
- New
- Public Device Record Key
- b0d65338-6f28-4b2a-bdc7-f33116d6b849
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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 57815 | CPAP/BPAP nasal mask, reusable | A flexible, form-shaped device designed to be placed over a user's nose 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 nose. 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 |
|---|---|---|---|---|---|---|
| Primary | 00606959060128 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210386 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity