Identity
- Trade Name
- PATTERSON MEDICAL FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- ECONOMY ANEROID SPHYGMOMANOMETER FDA UDI
- Model / Reference
- 081505940 FDA UDI
- Description
- ECONOMY ANEROID SPHYGMOMANOMETER FDA UDI
Identifiers
- Catalog Number
- 081505940 FDA UDI
- Primary DI / UDI-DI
- 00885914048245 FDA UDI
- 510(k) Number
- K092245 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Dimensions & Sizes
- Size
- Circumference — 19.5 Inch FDA UDI
Patterson Medical by Performance Health Supply, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092245 also covers:
- Blood Pressure Kit — Dynarex Corp.
- LABTRON — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, 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
- Performance Health Supply, LLC
Sources (1)
- FDA UDI 183680f5-3283-4604-86c8-2cd77213fdad 38 fields · synced May 30, 2026