FDA UDI
In Commercial Distribution
🇺🇸 United States
Aquanil Rescue Serum
DI: 00850015491863
·
Model: 86052
·
Sonoma Pharmaceuticals, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Aquanil Rescue Serum
- Primary DI
- 00850015491863
- Version / Model
- 86052
- Catalog Number
- 86052
- Company Name
- Sonoma Pharmaceuticals, Inc.
- Labeler DUNS
- 081642964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-04
- Public Version
- 1
- Public Version Date
- 2025-11-12
- Public Version Status
- New
- Public Device Record Key
- 62f0b68d-387b-40a7-99f9-608781de6c36
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850015491867 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00850015491863 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171935 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 28 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit