Identity
- Trade Name
- CARE ONE FDA UDI
- Generic Name
- Earplugs, reusable FDA UDI
- Device Name
- CARE ONE FLTMATE FDA UDI
- Model / Reference
- F407-006CO1 FDA UDI
- Description
- CARE ONE FLTMATE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00041520875563 FDA UDI
- FDA Product Code
- EWD FDA UDI
- GMDN Term
- Earplugs, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Earplugs, reusable
Care One by Apothecary Products, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earplugs, reusable.
- ULINE REUSABLE EARPLUGS - CORDED — ULINE, INC. · U
- Mack's — Mckeon Products · U
- Mack's — Mckeon Products · U
- Lucid Audio — ETYMOTIC RESEARCH, INC. · U
- Migraine stopper — Ningbo Albert Novosino Co., Ltd. · Class I
- Lucid Audio — ETYMOTIC RESEARCH, INC. · U
- Lucid Audio — ETYMOTIC RESEARCH, INC. · U
- Lucid Audio — ETYMOTIC RESEARCH, INC. · U
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apothecary Products, Inc.
Sources (1)
- FDA UDI c3e66bbc-b103-4826-8009-7d80bb874493 34 fields · synced Jun 6, 2026