Identity
- Trade Name
- PureLife Dental FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- PureLife ASTM Level 3 Earloop Face Masks, Lavender, ASTM Level 3: BFE >= 98%, Fluid-resistant, Latex-free ear loops, Metal nose piece, Packaging made from recycled material FDA UDI
- Model / Reference
- 1154903 FDA UDI
- Description
- PureLife ASTM Level 3 Earloop Face Masks, Lavender, ASTM Level 3: BFE >= 98%, Fluid-resistant, Latex-free ear loops, Metal nose piece, Packaging made from recycled material FDA UDI
Identifiers
- Catalog Number
- 1154903 FDA UDI
- Primary DI / UDI-DI
- D79011549031 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
PureLife Dental by Purelife, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, non-antimicrobial, single-use.
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- PRIMED — priMED Medical Products Inc · Class II
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- MEDICOM SAFEMASK CLASSICS — AMD Medicom Inc · Class II
- THE SEA — Mexpo International, Inc. · Class II
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
- Purelife, Llc
Sources (1)
- FDA UDI 03f73fbc-7c3e-48b3-b366-3a1e4807b022 35 fields · synced Jun 1, 2026