V-707 with Power Pack(100-120V) 61305

GUDID 04942962613057

ATOM MEDICAL CORPORATION

Transport infant incubator

• Primary Device ID: 04942962613057
• NIH Device Record Key: d64fa9ce-6a33-436d-9d67-f327bcba6629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-707 with Power Pack(100-120V)
• Version Model Number: 61305
• Catalog Number: 61305
• 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: +81488533661
• Email: hitoshi.hayashi@atomed.co.jp

Device Dimensions

• Depth: 44 Centimeter
• Width: 95 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04942962613057 [Primary]

FDA Product Code

• FPL: Incubator, Neonatal Transport

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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• 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