6126A

GUDID 40850015328013

ARC MEDICAL INC.

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 40850015328013
• NIH Device Record Key: 0403ad20-0482-4d0b-8bed-fec4ec01862e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6126A
• Version Model Number: 6126A
• Company DUNS: 624880720
• Company Name: ARC MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015328015 [Primary]
GS1	10850015328012 [Package]; Contains: 00850015328015; Package: [10 Units]; In Commercial Distribution
GS1	20850015328019 [Package]; Contains: 00850015328015; Package: [50 Units]; In Commercial Distribution
GS1	30850015328016 [Package]; Contains: 00850015328015; Package: [100 Units]; In Commercial Distribution
GS1	40850015328013 [Package]; Contains: 00850015328015; Package: [300 Units]; In Commercial Distribution
GS1	50850015328010 [Package]; Contains: 00850015328015; Package: [600 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090738

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-23
• Device Publish Date: 2020-01-15

Devices Manufactured by ARC MEDICAL INC.

• 20850015328002 - 6120A: 2020-01-23
• 40850015328013 - 6126A: 2020-01-23
• 40850015328013 - 6126A: 2020-01-23
• 50850015328027 - 6130A: 2020-01-23
• 40850015328037 - 7056A: 2020-01-23
• 40850015328044 - 6000A: 2020-01-23
• 40850015328051 - 6060A: 2020-01-23
• 50850015328065 - 6070A: 2020-01-23