Atom Infant Incubator 101 AC120V w/o O2 Controll 61607

GUDID 04942962616072

ATOM MEDICAL CORPORATION

Conventional infant incubator

• Primary Device ID: 04942962616072
• NIH Device Record Key: 422ebb74-8754-48cd-8ef3-39492cabf69b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atom Infant Incubator 101 AC120V w/o O2 Controll
• Version Model Number: 61607
• Catalog Number: 61607
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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 Dimensions

• Depth: 68 Centimeter
• Width: 107 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04942962616072 [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

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