FDA UDI
In Commercial Distribution
🇺🇸 United States
NeilMed Wound Wash
DI: 00705928652101
·
Model: WoundWash
·
NEILMED PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeilMed Wound Wash
- Primary DI
- 00705928652101
- Version / Model
- WoundWash
- Catalog Number
- WW-0NB-48-ENU-USL
- Company Name
- NEILMED PHARMACEUTICALS, INC.
- Labeler DUNS
- 799295915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-28
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 78587950-2a62-4f6b-b77e-163b013d7a05
Device Description
NeilMed Wound Wash - Sterile Saline Solution Ready to Use Isotonic-Drug Free-Preservative Free
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64871 | Non-antimicrobial wound irrigation solution, saline | A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), 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 may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00705928652101 | GS1 |
Customer Contacts
- Phone
- 1 (707) 525-3784
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123910 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 177.6 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 55 Degrees Celsius