FDA UDI
In Commercial Distribution
🇺🇸 United States
Superline
DI: 08809220580000
·
Model: SU001
·
SOOIL DEVELOPMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Superline
- Primary DI
- 08809220580000
- Version / Model
- SU001
- Company Name
- SOOIL DEVELOPMENT CO.,LTD
- Labeler DUNS
- 688006266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 8ec19e62-60ef-421e-883d-c4d32ce92ab2
Device Description
Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
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 |
|---|---|---|---|---|
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809220580434 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08809220580000 | GS1 | ||||
| Package | 18809220582728 | GS1 | 20 | In Commercial Distribution | ||
| Package | 18809220580960 | GS1 | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022317 | 000 |