FDA UDI
In Commercial Distribution
🇺🇸 United States
SOL-CARE™ Safety Winged Infusion Set
DI: 00818392018295
·
Model: 233412SI
·
SOL-MILLENNIUM MEDICAL INC
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SOL-CARE™ Safety Winged Infusion Set
- Primary DI
- 00818392018295
- Version / Model
- 233412SI
- Company Name
- SOL-MILLENNIUM MEDICAL INC
- Labeler DUNS
- 069590113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-03
- Public Version
- 2
- Public Version Date
- 2018-11-05
- Public Version Status
- Update
- Public Device Record Key
- 30a4003d-0d71-4ea2-847c-237a04589fc1
Device Description
SOL-CARE™ Safety Winged Infusion Set 23G*3/4*12”
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17825 | Scalp vein intravenous administration set | A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20818392018299 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 10818392018292 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00818392018295 | GS1 |
Customer Contacts
- Phone
- +1(404)973-2200
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tubing Length: 12 inches | ||
| Length | 20 | Millimeter | |
| Needle Gauge | 23 | Gauge |