Identity
- Trade Name
- ATTACHMENT FOR UWIT FDA UDI
- Generic Name
- Portable active medical device mount FDA UDI
- Device Name
- MAJ-2011 ATTACHMENT FOR UWIT FDA UDI
- Model / Reference
- MAJ-2011 FDA UDI
- Description
- MAJ-2011 ATTACHMENT FOR UWIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170327735 FDA UDI
- 510(k) Number
- K120278 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Portable active medical device mount FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable active medical device mount
Attachment For Uwit by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Portable active medical device mount.
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- CDI OneView™ Monitoring System — Terumo Cardiovascular Systems Corporation · Class II
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- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation · Class I
- CONSOLE STANDOFF DISTANCE HOLDER — Thoratec Switzerland GmbH · Class II
- CDI OneView™ Monitoring System — Terumo Cardiovascular Systems Corporation · Class II
Cleared under the same submission
K120278 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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI e951aaa7-f1d3-4348-8e50-dda67f516777 35 fields · synced Jun 1, 2026