Resp-O2 Air Cushion Mask with Valve, Size #3, Child/Sm Adult (Green Hook)

GUDID 00840117321700

Intended for use in anesthetic therapy

DYNAREX CORPORATION

Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use Anaesthesia face mask, single-use
Primary Device ID00840117321700
NIH Device Record Keyae7c8aa6-e208-4514-a62f-ea38704af9f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Air Cushion Mask with Valve, Size #3, Child/Sm Adult (Green Hook)
Version Model Number36033
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
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
GS100840117321649 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS100840117321700 [Primary]

FDA Product Code

BSJMask, Gas, Anesthetic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

Devices Manufactured by DYNAREX CORPORATION

00840117334151 - Dyna-Safety Nitrile Exam Gloves,Powder-Free,Blue,X-Large2024-03-26
00840117335868 - DynaSafety Sterile Gauze Pad, All Gauze 2024-03-26 3" x 3", 12-ply
08401173314574 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25
08401173314710 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25 1" x 3"
08401173314956 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25 1" x 3"
00840117331501 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25 1" x 3"
00840117334274 - Resp-O2 CPAP Tubing 4' ( 1.2m )2024-03-25
00840117334298 - Resp-O2 CPAP Tubing 6' ( 1.8 m )2024-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.