FDA UDI
In Commercial Distribution
🇺🇸 United States
Rexall Sterile Saline Wound Wash
DI: 00646011887409
·
Model: 88-50740-200-00
·
DOLGENCORP, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rexall Sterile Saline Wound Wash
- Primary DI
- 00646011887409
- Version / Model
- 88-50740-200-00
- Company Name
- DOLGENCORP, LLC
- Labeler DUNS
- 068331990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 1
- Public Version Date
- 2024-10-14
- Public Version Status
- New
- Public Device Record Key
- 2f7ff478-46ed-4ca3-bc01-d746579a579c
Device Description
Sterile Saline Wound Wash
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 62389 | Wound irrigation cannula | A rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00646011887409 | GS1 |
Customer Contacts
- Phone
- 615-855-4423
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 211 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit