Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Eye pad FDA UDI
- Device Name
- Phototherapy Eye Protector,Small FDA UDI
- Model / Reference
- MI00575 FDA UDI
- Description
- Phototherapy Eye Protector,Small FDA UDI
Identifiers
- Catalog Number
- MI00575 FDA UDI
- Primary DI / UDI-DI
- 10884527020027 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Inch FDA UDIWidth — 1.125 Inch FDA UDI
Category: Eye pad
Argyle by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye pad.
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
- Posey Eye Protection — NEOLIGHT LLC · Class I
- 36M - Class B Select - Metal — Certified Safety Manufacturing, Inc. · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
- FAC-3 - Lawson Class B — Certified Safety Manufacturing, Inc. · N
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI d7e50d82-8121-4a17-8ccc-a259b66c2d36 37 fields · synced May 30, 2026