Device
(Newborn) Phototherapy Protective Eye Mask
Manufacturer
Guangzhou Huiming Fibre Products Co., Ltd.
Guangzhou Huiming Fibre Products Co., Ltd.
Model: E201
DI: 06979379450041
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-08
Description
(Newborn) Phototherapy Protective Eye Mask
Disposable Neonatal Phototherapy Eye Mask designed to protect infants' eyes from blue light exposure during phototherapy treatment.
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
af7cd893-5005-4dc0-8fbd-1ace66669b54
Distribution Status:
In Commercial Distribution
DUNS Number:
526896695
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
06979379450041
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16979379450048
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
50
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
06979379450041
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
26979379450045
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
1500
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
06979379450041
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 64274
Name: Epiocular radiation shield, single-use
Definition:
An opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a single-use device.
FDA Product Codes
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)