Identity
- Trade Name
- CNAP® double finger cuff "medium" FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Device Name
- Unit, with Unlimited Lifecycle (600h) FDA UDI
- Model / Reference
- V4.4 FDA UDI
- Description
- Unit, with Unlimited Lifecycle (600h) FDA UDI
Identifiers
- Catalog Number
- 20-FVMA-15520U FDA UDI
- Primary DI / UDI-DI
- 09120073931641 FDA UDI
- 510(k) Number
- K082599 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient monitoring system module, blood pressure, noninvasive
CNAP® double finger cuff "medium" by CNSystems Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, blood pressure, noninvasive.
- Technicuff — Technicuff Corp. · Class II
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- Technicuff — Technicuff Corp. · Class II
- Rite365 — MAYBEAM LLC · Class II
- BOTHEALTH — Shenzhen BSX Technology Electronics Co., Ltd. · Class II
- Finapres — Finapres Medical Systems B.V. · Class II
- MedSource Blood Pressure Unit, Large Adult — MEDSOURCE INTERNATIONAL LLC · Class II
Cleared under the same submission
K082599 also covers:
- AUX: Analog Out connector — CNSystems Medizintechnik GmbH
- BP Wave Out: CNAP® transducer cable — CNSystems Medizintechnik GmbH
- BP Wave Out: CNAP® transducer cable — CNSystems Medizintechnik GmbH
- BP Wave Out: CNAP® transducer cable — CNSystems Medizintechnik GmbH
- CNAP® cable — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "large" — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "large" — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "large" — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "medium" — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "medium" — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "medium" — CNSystems Medizintechnik GmbH
- CNAP® double finger cuff "small" — CNSystems Medizintechnik GmbH
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
- CNSystems Medizintechnik GmbH
Sources (1)
- FDA UDI a3220893-be60-41c5-a70a-9aa957ea31b9 37 fields · synced May 30, 2026