AccessGUDID - DEVICE: NeoSeal® (10812594011594)

GUDID

Device Identifier (DI) Information

Brand Name: NeoSeal®
Version or Model: Small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N421
Company Name: Neotech Products LLC

Primary DI Number: 10812594011594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 150
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

Device Description: The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is 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?
64484	Patient tube cushion	A small patient-worn padding intended to function as a barrier between a patient tube/catheter (e.g., nasogastric tube, oxygen tube, surgical drain, laryngectomy or tracheostomy tube) and the skin to prevent irritation, maceration, and ulceration. It is typically made of a skin-friendly material (e.g., foam, silicone gel) designed to wrap/fit around the tube/catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXJ	Clip, Nose

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: 3eab6710-36a0-43f4-a19f-f4eaec06ba69
Public Version Date: September 20, 2023
Public Version Number: 4
DI Record Publish Date: May 19, 2021