Identity
- Trade Name
- NOVAPLUS FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Novaplus ASTM Fluid-Rated Fog-Free Procedure Mask, Blue, WrapAround Visor FDA UDI
- Model / Reference
- 47597 FDA UDI
- Description
- Novaplus ASTM Fluid-Rated Fog-Free Procedure Mask, Blue, WrapAround Visor FDA UDI
Identifiers
- Catalog Number
- 47597 FDA UDI
- Primary DI / UDI-DI
- 20680651475972 FDA UDI
- 510(k) Number
- K823078 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
Novaplus by O&M Halyard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical/medical face mask, non-antimicrobial, single-use.
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- Criterion — HENRY SCHEIN, INC. · Class II
- PRIMED — priMED Medical Products Inc · Class II
- MEDICOM SAFEMASK CLASSICS — AMD Medicom Inc · Class II
- THE SEA — Mexpo International, Inc. · Class II
- iSmile — ISMILE DENTAL PRODUCTS INC. · Class II
Cleared under the same submission
K823078 also covers:
- KIMBERLY-CLARK® Fluidshield* Fog-Free Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Fog-Free Procedure Mask with Visor — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Fog-Free Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Fog-Free Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Fluidshield™ Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Procedure Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® Soft Touch™ II Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMBERLY-CLARK® The Lite One™ Surgical Mask — KIMBERLY-CLARK GLOBAL SALES, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
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
- O&M Halyard, Inc.
Sources (1)
- FDA UDI 5b4d9f30-d7d2-4d06-a3ac-1a6cd7cb16f5 36 fields · synced May 30, 2026