Patient Circuit 60386

GUDID 14942962603864

ATOM MEDICAL CORPORATION

Respiratory oxygen therapy system

• Primary Device ID: 14942962603864
• NIH Device Record Key: bcd44b1d-9994-40c7-8a08-1980633b7007
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Circuit
• Version Model Number: 60386
• Catalog Number: 60386
• Company DUNS: 690632047
• Company Name: ATOM MEDICAL CORPORATION
• 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: true
• 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

Customer Support Contacts

• Phone: +81 488533661
• Email: hitoshi.hayashi@atomed.co.jp

Device Dimensions

• Outer Diameter: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04942962603867 [Primary]
GS1	14942962603864 [Package]; Contains: 04942962603867; Package: box [5 Units]; In Commercial Distribution

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-29
• Device Publish Date: 2015-09-08

Devices Manufactured by ATOM MEDICAL CORPORATION

• 04942962261227 - Mattress Sheet for Neo Cot(5 pcs/pkg): 2019-01-29
• 04942962601450 - Face Mask For Neonatal(20 pcs/box): 2019-01-29
• 04942962601467 - Face Mask For Infant(20 pcs/box): 2019-01-29
• 04942962602167 - Infa Lite AC100-240V: 2019-01-29
• 04942962602693 - Pneumoclean Electrostatic Filter(5 pcs/pkg): 2019-01-29
• 04942962602983 - Test Bag, 50mL: 2019-01-29
• 04942962603058 - Oxygen Sensor For V-808: 2019-01-29
• 04942962603171 - Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-8: 2019-01-29