FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentinel
DI: D915MPI21
·
Model: MPI2
·
Plastcare USA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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
- Sentinel
- Primary DI
- D915MPI21
- Version / Model
- MPI2
- Company Name
- Plastcare USA
- Labeler DUNS
- 079299604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-12-12
- Public Version
- 4
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 8ca5084e-fa33-423b-95c3-d3f45a66a0d8
Device Description
Earloop Mask - Pink ASTM Level 2
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
- MR Safe
- 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 |
|---|---|---|---|---|
| FXX | Mask, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57794 | Surgical/medical respirator, non-antimicrobial, single-use | A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D915MPI22 | HIBCC | 20 | In Commercial Distribution | ||
| Primary | D915MPI21 | HIBCC | ||||
| Unit of Use | D915MPI20 | HIBCC |