FDA UDI
In Commercial Distribution
🇺🇸 United States
Shield
DI: H816MPFL0081
·
Model: PFL008
·
MicroCare, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
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Basic Information
- Brand Name
- Shield
- Primary DI
- H816MPFL0081
- Version / Model
- PFL008
- Catalog Number
- PFL008-1
- Company Name
- MicroCare, LLC
- Labeler DUNS
- 118518186
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-10-26
- Public Version
- 1
- Public Version Date
- 2022-11-03
- Public Version Status
- New
- Public Device Record Key
- 47850919-b356-4226-8db8-b74a731b8100
Device Description
High-Efficiency Face 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
- 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 |
|---|---|---|---|---|
| 66199 | Surgical/medical face mask, non-antimicrobial, single-use | A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H816MPFL0082 | HIBCC | Case Box | 6 | In Commercial Distribution | |
| Primary | H816MPFL0081 | HIBCC | ||||
| Unit of Use | H816MPFL0080 | HIBCC | ||||
| Previous | H816PFL0081 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K890128 | 000 |