FDA UDI
In Commercial Distribution
🇺🇸 United States
SURFLO™
DI: 05413206054909
·
Model: SV-S25BL35
·
Terumo Europe NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SURFLO™
- Primary DI
- 05413206054909
- Version / Model
- SV-S25BL35
- Catalog Number
- SV-S25BL35
- Company Name
- Terumo Europe NV
- Labeler DUNS
- 370193559
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 5
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- 448daf52-a05f-4e1b-af70-c115d48592cf
Device Description
SURFLO™ WINGED INFUSION SET WITH NEEDLE PROTECTION
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
- 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
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65416 | Basic intravenous administration set, invasive | A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 55413206054904 | GS1 | Carton | 1000 | In Commercial Distribution | |
| Primary | 05413206054909 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133867 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Dead Space Volume: 0.40 Milliliter | ||
| Device Size Text, specify | Tube Length: 35 Centimeter | ||
| Device Size Text, specify | Tube Length: 13.8 Inch | ||
| Device Size Text, specify | Needle Length: 19 Millimeter | ||
| Device Size Text, specify | Needle Outer Diameter: 0.5 Millimeter | ||
| Device Size Text, specify | Needle Length: 0.75 Inch | ||
| Needle Gauge | 25 | Gauge | |
| Device Size Text, specify | Thin Wall |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius