FDA UDI
In Commercial Distribution
🇺🇸 United States
SafeWash Saline
DI: 00714196245076
·
Model: 00245
·
DERMARITE INDUSTRIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SafeWash Saline
- Primary DI
- 00714196245076
- Version / Model
- 00245
- Company Name
- DERMARITE INDUSTRIES LLC
- Labeler DUNS
- 883925562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 972fd3bf-a11c-486e-9c55-5601dd4c2e0e
Device Description
SafeWash™ Saline is a sterile first-aid, multi-use jet lavage for wound dressing irrigation and wound cleansing. SafeWash™ Saline wound wash is intended for: moistening and lubricating absorbent wound dressings; cleansing wounds, scrapes and minor burns; flushing and cleansing wounds of exudate, loose necrotic tissue, and foreign material such as dirt and debris. Contains 0.9% Sodium Chloride Solution.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQH | Lavage, Jet | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37298 | Wound irrigation sterile saline | A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00714196245076 | GS1 | ||||
| Package | 10714196245073 | GS1 | Case | 12 | In Commercial Distribution |