Atom Phototherapy Analyzer Ⅱ 68448

GUDID 04942962684484

ATOM MEDICAL CORPORATION

Photometer, reflectance

• Primary Device ID: 04942962684484
• NIH Device Record Key: f1902d15-4d1b-4725-b62c-9cfdad1a5e6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atom Phototherapy Analyzer Ⅱ
• Version Model Number: 68448
• Catalog Number: 68448
• Company DUNS: 690632047
• Company Name: ATOM MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04942962684484 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

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: 2016-09-21

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