Identity
- Trade Name
- MyCite Patch FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- DW5 replacement patch FDA UDI
- Model / Reference
- DW5 FDA UDI
- Description
- DW5 replacement patch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857335005053 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
MyCite Patch by Otsuka America Pharmaceutical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Otsuka America Pharmaceutical Inc
Sources (1)
- FDA UDI 8f2d11ac-9309-4416-b1cf-2122ac9a4cd8 36 fields · synced Jun 8, 2026