AccessGUDID - DEVICE: NeoShades® with Tabs (10812594013185)

GUDID

Device Identifier (DI) Information

Brand Name: NeoShades® with Tabs
Version or Model: Large with Ocular Pockets Plain
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N726PL
Company Name: Neotech Products LLC

Primary DI Number: 10812594013185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

Device Description: The NeoShades are indicated for use as eye protection during phototherapy sessions. They are intended for use on pediatric (neonates, infants and children) patients.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35063	Eye mask	A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOK	Pad, Neonatal Eye

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36e45fb6-d0cc-4601-a653-1badc0ed508d
Public Version Date: September 21, 2023
Public Version Number: 3
DI Record Publish Date: May 18, 2021