Resp-O2 Suction Unit

GUDID 00840117309609

Resp-O2 Suction Unit, Vacuum Levels up to 560 mmHg

DYNAREX CORPORATION

Emergency airway clearance suction pump, electric
Primary Device ID00840117309609
NIH Device Record Key0eac6261-0996-4a28-acae-aa0a110667ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Suction Unit
Version Model Number32300
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117309609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-17
Device Publish Date2022-05-09

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.