Identity
- Trade Name
- ViSi FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- Chest Sensor Securements, 3M FDA UDI
- Model / Reference
- Chest Sensor Securements, 3M (Qty 100) FDA UDI
- Description
- Chest Sensor Securements, 3M FDA UDI
Identifiers
- Catalog Number
- 94-10012 FDA UDI
- Primary DI / UDI-DI
- 10850733007305 FDA UDI
- 510(k) Number
- K152341 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Category: Dressing-fixation skin adhesive tape, non-silicone
ViSi by Sotera Wireless — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152341 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sotera Wireless
Sources (1)
- FDA UDI ffa4c2fa-c4fe-401d-b7ae-c278f002ffb0 35 fields · synced Jun 6, 2026