Resp-O2 Air Cushion Mask with Valve, Size #2, Toddler, (Yellow Hook)

GUDID 00840117321694

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 ID00840117321694
NIH Device Record Keyb762f898-3c29-4177-aff9-5565f1f9e3dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Air Cushion Mask with Valve, Size #2, Toddler, (Yellow Hook)
Version Model Number36032
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
GS100840117321632 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS100840117321694 [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

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