Identity
- Trade Name
- Newborn Silicone Dummy FDA UDI
- Generic Name
- Infant care kit FDA UDI
- Model / Reference
- TPS010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09420060209013 FDA UDI
- FDA Product Code
- MEF FDA UDI
- GMDN Term
- Infant care kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infant care kit
Newborn Silicone Dummy by Think Green Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Safety 1st — DOREL JUVENILE GROUP, INC. · Class II
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class II
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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
- Think Green Limited
Sources (1)
- FDA UDI 612e6d73-ac1c-4d65-abc3-f76a8bc39511 33 fields · synced May 30, 2026