Identity
- Trade Name
- EyeMax2 FDA UDI
- Generic Name
- Phototherapy infant blanket FDA UDI
- Device Name
- EyeMax2 Kit (Contains a 20/pack each of Regular, Preemie, and Micro) FDA UDI
- Model / Reference
- Kit FDA UDI
- Description
- EyeMax2 Kit (Contains a 20/pack each of Regular, Preemie, and Micro) FDA UDI
Identifiers
- Catalog Number
- R300P16 FDA UDI
- Primary DI / UDI-DI
- 00817770020561 FDA UDI
- FDA Product Code
- FOK FDA UDI
- GMDN Term
- Phototherapy infant blanket 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Phototherapy infant blanket
EyeMax2 by Maxtec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phototherapy infant blanket.
- EyeMax2 — Maxtec, Inc. · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- EyeMax2 — Maxtec, Inc. · Class I
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
- Maxtec, Inc.
Sources (1)
- FDA UDI a90fef64-1697-4b92-9275-b8bf0b04313f 34 fields · synced May 31, 2026