Procare Spacer Chamber

GUDID 00372217039037

Spacer Chamber without Mask

ARISE MEDICAL LLC

Medicine chamber spacer, reusable
Primary Device ID00372217039037
NIH Device Record Keya75ab517-d085-4f49-abc0-984dee199bc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcare Spacer Chamber
Version Model Number240530
Company DUNS081149273
Company NameARISE MEDICAL LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100372217039037 [Primary]

FDA Product Code

NVPHolding Chambers, 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 Date2020-08-31
Device Publish Date2020-08-22

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