Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, single-use FDA UDI
- Device Name
- CODE CART DRAWER 3 FDA UDI
- Model / Reference
- AN01234 FDA UDI
- Description
- CODE CART DRAWER 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10194717117711 FDA UDI
- FDA Product Code
- OEV FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Regard™ by Roi Cps, Llc — 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
- Roi Cps, Llc
Sources (1)
- FDA UDI b3fd9b61-0cb7-49be-b1b8-f9aa72d14ab8 34 fields · synced Jun 6, 2026