6126A

GUDID 40850015328013

ARC MEDICAL INC.

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID40850015328013
NIH Device Record Key0403ad20-0482-4d0b-8bed-fec4ec01862e
Commercial Distribution StatusIn Commercial Distribution
Brand Name6126A
Version Model Number6126A
Company DUNS624880720
Company NameARC MEDICAL INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100850015328015 [Primary]
GS110850015328012 [Package]
Contains: 00850015328015
Package: [10 Units]
In Commercial Distribution
GS120850015328019 [Package]
Contains: 00850015328015
Package: [50 Units]
In Commercial Distribution
GS130850015328016 [Package]
Contains: 00850015328015
Package: [100 Units]
In Commercial Distribution
GS140850015328013 [Package]
Contains: 00850015328015
Package: [300 Units]
In Commercial Distribution
GS150850015328010 [Package]
Contains: 00850015328015
Package: [600 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

Devices Manufactured by ARC MEDICAL INC.

20850015328002 - 6120A2020-01-23
40850015328013 - 6126A2020-01-23
40850015328013 - 6126A2020-01-23
50850015328027 - 6130A2020-01-23
40850015328037 - 7056A2020-01-23
40850015328044 - 6000A2020-01-23
40850015328051 - 6060A2020-01-23
50850015328065 - 6070A2020-01-23

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