FDA UDI
In Commercial Distribution
🇺🇸 United States
Hopkins Medical Products®
DI: 00817643020209
·
Model: 34210
·
HOPKINS UNIFORM COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hopkins Medical Products®
- Primary DI
- 00817643020209
- Version / Model
- 34210
- Catalog Number
- 34210
- Company Name
- HOPKINS UNIFORM COMPANY
- Labeler DUNS
- 003080678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-28
- Public Version
- 1
- Public Version Date
- 2018-10-29
- Public Version Status
- New
- Public Device Record Key
- dd68ce6e-1700-48d4-9500-fdb797db50e6
Device Description
Saline Wound Wash 7.1 Oz Spray Can Safewash
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 | 00817643020209 | GS1 |
Customer Contacts
- Phone
- +1(800)835-1995
- [email protected]