FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PRIMED
DI: 00842942017490
·
Model: PG4-1682
·
priMED Medical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- PRIMED
- Primary DI
- 00842942017490
- Version / Model
- PG4-1682
- Company Name
- priMED Medical Products Inc
- Labeler DUNS
- 253287569
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-11-25
- Public Version
- 1
- Public Version Date
- 2025-12-03
- Public Version Status
- New
- Public Device Record Key
- 5dedc4c8-bd23-4fc2-be90-c7c9c417316f
- Distribution End Date
- 2025-12-01
Device Description
ASTM F2100 Level 2 Pediatric Mask | Ear Loops | Dinosaur Pattern
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OXZ | Pediatric/Child Facemask | 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 | 10842942017497 | GS1 | Case | 10 | Not in Commercial Distribution | 2025-12-01 |
| Primary | 00842942017490 | GS1 | ||||
| Unit of Use | 90842942017493 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight.