Identity
- Trade Name
- Superline FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SU001 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809220580000 FDA UDI
- 510(k) Number
- K022317 FDA UDI
- FDA Product Code
- LZG FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electric infusion pump administration set, single-use
Superline by Sooil Development Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric infusion pump administration set, single-use.
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- CADD — ICU MEDICAL, INC. · Class II
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- Infusomat® — B. BRAUN MEDICAL INC. · Class II
Cleared under the same submission
K022317 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sooil Development Co., Ltd
Sources (1)
- FDA UDI 8ec19e62-60ef-421e-883d-c4d32ce92ab2 34 fields · synced May 31, 2026