6130A

GUDID 50850015328027

ARC MEDICAL INC.

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID50850015328027
NIH Device Record Key8ba3d53c-3da3-4de6-947c-a45c309941f4
Commercial Distribution StatusIn Commercial Distribution
Brand Name6130A
Version Model Number6130A
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
GS100850015328022 [Primary]
GS110850015328029 [Package]
Contains: 00850015328022
Package: [10 Units]
In Commercial Distribution
GS120850015328026 [Package]
Contains: 00850015328022
Package: [50 Units]
In Commercial Distribution
GS130850015328023 [Package]
Contains: 00850015328022
Package: [100 Units]
In Commercial Distribution
GS140850015328020 [Package]
Contains: 00850015328022
Package: [300 Units]
In Commercial Distribution
GS150850015328027 [Package]
Contains: 00850015328022
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
50850015328027 - 6130A2020-01-23
50850015328027 - 6130A2020-01-23
40850015328037 - 7056A2020-01-23
40850015328044 - 6000A2020-01-23
40850015328051 - 6060A2020-01-23
50850015328065 - 6070A2020-01-23

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