Identity
- Trade Name
- MyCite Patch FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- 2 component patch RW2 FDA UDI
- Model / Reference
- RW2 FDA UDI
- Description
- 2 component patch RW2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857335005091 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
- 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
Yes
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
Category: Wearable multiple physiological parameter recorder, reusable
MyCite Patch by Otsuka America Pharmaceutical Inc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Otsuka America Pharmaceutical Inc
Sources (1)
- FDA UDI cf349dc5-f295-4841-82f1-9c55363989a2 36 fields · synced May 30, 2026