Identity
- Trade Name
- Bili-Bonnet FDA UDI
- Generic Name
- Eye pad FDA UDI
- Device Name
- Bili-Bonnet Newborn size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice. FDA UDI
- Model / Reference
- 01B FDA UDI
- Description
- Bili-Bonnet Newborn size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice. FDA UDI
Identifiers
- Catalog Number
- 01B FDA UDI
- Primary DI / UDI-DI
- 00815090010019 FDA UDI
- FDA Product Code
- FOK FDA UDI
- GMDN Term
- Eye pad FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5270 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eye pad
Bili-Bonnet by Small Beginnings, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Small Beginnings, Inc.
Sources (1)
- FDA UDI 39e7438a-4a5e-4479-90ef-45f4e06c5d53 35 fields · synced May 30, 2026