7056A

GUDID 40850015328037

ARC MEDICAL INC.

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID40850015328037
NIH Device Record Key58f6244a-a89d-4d4e-8211-db4f91a53644
Commercial Distribution StatusIn Commercial Distribution
Brand Name7056A
Version Model Number7056A
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
GS100850015328039 [Primary]
GS110850015328036 [Package]
Contains: 00850015328039
Package: [50 Units]
In Commercial Distribution
GS120850015328033 [Package]
Contains: 00850015328039
Package: [100 Units]
In Commercial Distribution
GS130850015328030 [Package]
Contains: 00850015328039
Package: [300 Units]
In Commercial Distribution
GS140850015328037 [Package]
Contains: 00850015328039
Package: [1200 Units]
In Commercial Distribution
GS150850015328034 [Package]
Contains: 00850015328039
Package: [10 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
40850015328037 - 7056A2020-01-23
40850015328037 - 7056A2020-01-23
40850015328044 - 6000A2020-01-23
40850015328051 - 6060A2020-01-23
50850015328065 - 6070A2020-01-23

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