SpO2 Unit(Masimo) 61621

GUDID 04942962616218

ATOM MEDICAL CORPORATION

Conventional infant incubator

• Primary Device ID: 04942962616218
• NIH Device Record Key: e66c160c-af10-4338-b043-5b51525c6bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Unit(Masimo)
• Version Model Number: 61621
• Catalog Number: 61621
• Company DUNS: 690632047
• Company Name: ATOM MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• 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	04942962616218 [Primary]

FDA Product Code

• FMZ: Incubator, Neonatal

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

On-Brand Devices [SpO2 Unit(Masimo)]

• 04942962616256: 61625
• 04942962616218: 61621