FDA UDI
In Commercial Distribution
🇺🇸 United States
SURFLO
DI: 36927675515385
·
Model: SV*21BLS
·
Terumo Medical Products (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- SURFLO
- Primary DI
- 36927675515385
- Version / Model
- SV*21BLS
- Catalog Number
- SV*21BLS
- Company Name
- Terumo Medical Products (Hangzhou) Co., Ltd.
- Labeler DUNS
- 544830912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-08-11
- Public Version
- 1
- Public Version Date
- 2023-08-21
- Public Version Status
- New
- Public Device Record Key
- 51611b86-2c8c-4da4-9f88-d43ef794a99b
Device Description
SURFLO Winged Infusion Set
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 |
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 | 56927675515389 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 36927675515385 | GS1 | ||||
| Unit of Use | 06927675515384 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221411 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tubing Length:3.5inch | ||
| Device Size Text, specify | Type: Ultra-Thin Wall (UTW) | ||
| Total Volume | 0.20 | Milliliter | |
| Length | 0.75 | Inch | |
| Needle Gauge | 21 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- " DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."