Identity
- Trade Name
- ASP MEDICAL FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- MASK, LVL 2 FACE, BLUE W/HEARTS, EARLOOPS, 3-PLY, ASTM 1862, 50EA/BX, 40BX/CS (2000EA/CS) FDA UDI
- Model / Reference
- FMT605HEART FDA UDI
- Description
- MASK, LVL 2 FACE, BLUE W/HEARTS, EARLOOPS, 3-PLY, ASTM 1862, 50EA/BX, 40BX/CS (2000EA/CS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216110922 FDA UDI
- 510(k) Number
- K182515 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Asp Medical by Asp Global, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K182515 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI ca6e032f-ba24-4c40-9b25-535a0696be96 35 fields · synced May 30, 2026