Pedi-Neb™ 0383

GUDID 10889483223314

Pedi-Neb™ Nasal Nebulizer

SUNMED, LLC

Nebulizing system delivery set, single-use
Primary Device ID10889483223314
NIH Device Record Key773a1144-cd5e-4183-836e-497a503b5fc0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePedi-Neb™
Version Model Number0383
Catalog Number0383
Company DUNS069009268
Company NameSUNMED, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078001598 [Previous]
GS110889483223314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-08
Device Publish Date2025-12-31

On-Brand Devices [Pedi-Neb™ ]

20889483495749Pedi-Neb™ Nasal Nebulizer
20889483227388Pedi-Neb™ Nasal Nebulizer
20889483223588Pedi-Neb™ Small Volume Nebulizer, Pacifier with Adaptor
10889483223314Pedi-Neb™ Nasal Nebulizer

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