Identity
- Trade Name
- Q-Care FDA UDI
- Generic Name
- Oral care kit, single-use FDA UDI
- Device Name
- Q-Care, Q2, Oral Cleansing & Suctioning System FDA UDI
- Model / Reference
- 6422 FDA UDI
- Description
- Q-Care, Q2, Oral Cleansing & Suctioning System FDA UDI
Identifiers
- Catalog Number
- 6422 FDA UDI
- Primary DI / UDI-DI
- 00618029830319 FDA UDI
- FDA Product Code
- JOL FDA UDIKXF FDA UDINSB FDA UDI
- GMDN Term
- Oral care kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI880.6025 FDA UDI872.6855 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental suction system cannula, single-useBasic manual toothbrushOral care kit, single-useDental tooth-cleaning solution
Q-Care by Sage Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral care swab.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Centurion — Centurion Medical Products · Class I
- Centurion — Centurion Medical Products · Class I
- Oral Swabsticks, Unflavored — Dynarex Corp. · Class I
- Moisturizer — SMD MANUFACTURING LLC · Class II
- Oral Swabsticks, Flavored w/Dentifrice — Dynarex Corp. · Class I
- BALLARD — Avanos Medical, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sage Products Llc
Sources (1)
- FDA UDI a5d3d866-48dd-47e7-9830-c249f760cda4 35 fields · synced May 30, 2026