Identity
- Trade Name
- Green Sprouts FDA UDI
- Generic Name
- Infant care kit FDA UDI
- Device Name
- Cool Nature Teether - Green/Aqua Set FDA UDI
- Model / Reference
- 385345-500-33 FDA UDI
- Description
- Cool Nature Teether - Green/Aqua Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00715418178998 FDA UDI
- FDA Product Code
- KKO FDA UDI
- GMDN Term
- Infant care kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5550 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Green Sprouts by O2cool, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- O2cool, LLC
Sources (1)
- FDA UDI d976c1e0-86d5-4aa9-a46e-7d3091f958a6 34 fields · synced May 30, 2026