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

00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO 2025-08-27
00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic 2025-08-11 Sterile-EO
00616784704210 - IV Administration Sets, 10 mL, Non-Toxic 2025-08-11 Sterile-EO
00616784704418 - IV Administration Set, 20 mL, Non-Toxic2025-08-11 Sterile-EO
00616784304113 - Dmecare Solutions Solid Seat Insert2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.
00616784304212 - DMECare Solutions Solid Seat Insert2025-07-17 Solid Seat Insert 18"x 16". Weight Capacity: 300 LB
00616784304311 - DMECare Solutions Solid Seat Insert2025-07-17 Solid Seat Insert 20" x 16". Weight Capacity: 300 LB
00616784304410 - DMECare Solutions Solid Seat Insert2025-07-17 Solid Seat Insert 22" x 18" Weight Capacity: 300 LB

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