Identity
- Trade Name
- statMAP FDA UDI
- Generic Name
- Manual-inflation electronic sphygmomanometer, portable FDA UDI
- Device Name
- Re-manufactured electronic, hand-held, battery operated blood pressure measurement device. FDA UDI
- Model / Reference
- Re-manufactured FDA UDI
- Description
- Re-manufactured electronic, hand-held, battery operated blood pressure measurement device. FDA UDI
Identifiers
- Catalog Number
- 7200-9999 FDA UDI
- Primary DI / UDI-DI
- 00860498002616 FDA UDI
- 510(k) Number
- K072109 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Manual-inflation electronic sphygmomanometer, portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual-inflation electronic sphygmomanometer, portable
statMAP by Ramsey Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual-inflation electronic sphygmomanometer, portable.
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- Surelife — MHC Medical Products · Class II
- Surelife — MHC Medical Products · Class II
- Vaunn — EINSTEIN ASSOCIATES LLC · Class II
Cleared under the same submission
K072109 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
- Ramsey Medical, Inc.
Sources (1)
- FDA UDI b053f9c1-2b20-4831-aeee-4e2599dba4f3 37 fields · synced Jun 8, 2026