Eu Mdr Eu Md Class 1 On The Market 🇺🇸 United States

PCA-A400 Extension Cable

QT Medical, Inc. · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04719872981350
Basic UDI-DI Code
04719872981350VF
Reference
PCA-A400
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
QT Medical, Inc.

Additional Description

a. Users should visually inspect and remove any debris from the products before and after using the device. b. The Cable is designed for use with ECG devices. Users are responsible for checking the compatibility of the ECG device before use, as incompatible components can result in degraded performance. c. Never immerse the product in any liquid. Protect from strong UV radiation. d. Do not sterilize the Products by autoclave, radiation, or steam. e. Do not use lotion or oil before using the Products. The skin must be clean and dry while using. f. The Products contain thermoplastic polyurethane, which may cause allergic reactions in some patients and users. g. Do not use the product device if it is broken. Please visually check that the product device is in working order. h. The Patient Cable is non-Defibrillation-proof. DO NOT use a defibrillator.

CND Nomenclature Codes

Code Description
Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES

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