Compact Compressor Nebulizer

GUDID 00616784561639

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00616784561639
NIH Device Record Keye2b618ed-6ccf-4358-8900-87eac2929841
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompact Compressor Nebulizer
Version Model Number5616
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784561615 [Unit of Use]
GS100616784561639 [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 Date2019-05-29
Device Publish Date2019-05-21

Devices Manufactured by DYNAREX CORPORATION

00810180842716 - Electrode Skin Prep Pads2026-02-17
00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g 2026-02-04
00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet2026-02-03
00840117348790 - Flavored Oral Swab, For Professional And Hospital use 2026-01-29 Individually Wrapped
00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use2026-01-29 Individually Wrapped
00840117348837 - Oral Swabsticks, Flavored w/Dentrifice2026-01-29
00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use2026-01-29
00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.