Identity
- Trade Name
- Family Wellness Saline Wound Wash FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, saline FDA UDI
- Device Name
- Sterile Saline Wound Wash. Packaged in an aerosol (BOV). FDA UDI
- Model / Reference
- 997345 FDA UDI
- Description
- Sterile Saline Wound Wash. Packaged in an aerosol (BOV). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00032251985164 FDA UDI
- FDA Product Code
- FQH FDA UDIFRO FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, saline FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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: Non-antimicrobial wound irrigation solution, saline
Family Wellness Saline Wound Wash by Family Dollar Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-antimicrobial wound irrigation solution, saline.
- SteriCare Solutions — NURSE ASSIST, INC. · U
- Saljet — WINCHESTER LABORATORIES, LLLP · U
- SteriCare Solutions — NURSE ASSIST, INC. · U
- Premier Solution Saline Wound Wash — Premier Brands of America, Inc. · Class II
- NeilMed Wound Wash — NeilMed Pharmaceuticals Inc. · U
- SteriCare Solutions — NURSE ASSIST, INC. · U
- Caring Mill Saline Wound Wash — Caring Mill · Class II
- AMSafe ® Pre-Filled Normal Saline Flush Syringe — AMSINO 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
- Family Dollar Stores
Sources (1)
- FDA UDI b20ccca2-d159-4b62-b68a-962edc516717 34 fields · synced Jun 6, 2026