Identity
- Trade Name
- Neonate Cuff FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- NEONATAL DISPOSABLE CUFFS SIZE 3 [6.0-11.0 CM] (20 PER BOX) FDA UDI
- Model / Reference
- 1009-001642 FDA UDI
- Description
- NEONATAL DISPOSABLE CUFFS SIZE 3 [6.0-11.0 CM] (20 PER BOX) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946026806 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
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, single-use
Neonate Cuff by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Zoll Medical Corporation
Sources (1)
- FDA UDI 9461d396-673c-4fbd-ac66-04f6d6077188 35 fields · synced Jun 8, 2026