Identity
- Trade Name
- MY-CUF FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- MY-CUF, ADULT, 2 DINACLICK, 23 - 33 CM, SINGLE FDA UDI
- Model / Reference
- MY-A2-2A FDA UDI
- Description
- MY-CUF, ADULT, 2 DINACLICK, 23 - 33 CM, SINGLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682116268 FDA UDI
- 510(k) Number
- K120125 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Blood pressure cuff, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
My-Cuf by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120125 also covers:
- CLASSIC-CUF — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- DURA-CUF — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SOFT-CUF — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SOFT-CUF — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SOFT-CUF — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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
- Ge Medical Systems Information Technologies, Inc.
Sources (1)
- FDA UDI 1632e98a-4bfa-4f00-9201-2d967372ff78 37 fields · synced Jun 8, 2026