Transducer Belt - Button - Single Patient Use - 10 Box
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- TRANSDUCER BELT – BUTTON - SINGLE PATIENT USE – 10/Box EUDAMEDTRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Device Name
- Transducer Belt EUDAMEDTRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10/BOX FDA UDI
- Model / Reference
- 2015827-001 EUDAMEDB1 FDA UDI
- Description
- TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10/BOX FDA UDI
Identifiers
- Catalog Number
- 2015827-001 FDA UDI
- Primary DI / UDI-DI
- 00840682142724 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00129H9 EUDAMED
- Direct Marketing DI
- 00840682142724 EUDAMED
- FDA Product Code
- FSD FDA UDI
- EMDN Code
- Z1208010485 CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electrode/transducer strap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5160 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrode/transducer strap, reusable
The TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX medical device is a single-use, button-style transducer belt designed for use on patients. It features a sterile design and is exempt from PM exemptions. This device does not require expiration dates or manufacturing dates, but its labeling indicates that it meets certain safety standards.
Similar devices
Also classified as Electrode/transducer strap, reusable.
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- Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wipro GE Healthcare Private Ltd
Sources (2)
- FDA UDI 33fc6b61-66ad-4719-8522-3fec3668993c 35 fields · synced Jul 26, 2026
- EUDAMED 0bd63cc1-8cfb-451d-be75-135be836e765 61 fields · synced Jul 26, 2026