Identity
- Trade Name
- TEMPERATURE SENSING FOLEY BALLOON CATHETER FDA UDI
- Generic Name
- Temperature-monitoring indwelling urethral drainage catheter FDA UDI
- Device Name
- Temperature Sensing/Blue 3cc 10fr FDA UDI
- Model / Reference
- 2105-010 FDA UDI
- Description
- Temperature Sensing/Blue 3cc 10fr FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806369403726 FDA UDI
- 510(k) Number
- K022287 FDA UDI
- FDA Product Code
- EZL FDA UDI
- GMDN Term
- Temperature-monitoring indwelling urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
No
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: Temperature-monitoring indwelling urethral drainage catheter
Temperature Sensing Foley Balloon Catheter by Sewoon Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temperature-monitoring indwelling urethral drainage catheter.
- All Silicone Foley Catheter with Temperature Sensor — Well Lead Medical Co., Ltd · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Covidien AG — DEGANIA SILICONE LTD · Class II
- Covidien AG — DEGANIA SILICONE LTD · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K022287 also covers:
- TEMPERATURE SENSING FOLEY BALLOON CATHETER — Sewoon Medical Co., Ltd.
- TEMPERATURE SENSING FOLEY BALLOON CATHETER — Sewoon Medical Co., Ltd.
- TEMPERATURE SENSING FOLEY BALLOON CATHETER — Sewoon Medical Co., Ltd.
- TEMPERATURE SENSING FOLEY BALLOON CATHETER — Sewoon Medical Co., Ltd.
- TEMPERATURE SENSING FOLEY BALLOON CATHETER — Sewoon Medical Co., Ltd.
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
- Sewoon Medical Co., Ltd.
Sources (1)
- FDA UDI ea3ed538-b07d-49b2-bc68-54bbdfd9ae81 34 fields · synced May 31, 2026