Identity
- Trade Name
- LEAF™ FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting, standing or lying down –on their left side, right side or back. FDA UDI
- Model / Reference
- 66803060 FDA UDI
- Description
- A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting, standing or lying down –on their left side, right side or back. FDA UDI
Identifiers
- Catalog Number
- 66803060 FDA UDI
- Primary DI / UDI-DI
- 05000223497439 FDA UDI
- FDA Product Code
- KMI FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
Leaf™ by Smith & Nephew Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 4a3b0ccb-a534-40a3-8091-0fbc21c067f7 35 fields · synced May 31, 2026