Neo Sheets(100 pcs/box) 60337

GUDID 04942962603379

ATOM MEDICAL CORPORATION

Conductive bed mattress cover

• Primary Device ID: 04942962603379
• NIH Device Record Key: 320da13e-d56e-465b-aba5-835611e5026e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo Sheets(100 pcs/box)
• Version Model Number: 60337
• Catalog Number: 60337
• Company DUNS: 690632047
• Company Name: ATOM MEDICAL CORPORATION
• Device Count: 5
• 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: true
• Lot Batch: false
• Serial Number: false
• 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	04942962603379 [Primary]
GS1	14942962603376 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	24942962603373 [Package]; Contains: 14942962603376; Package: Box [2 Units]; In Commercial Distribution
GS1	84942962603375 [Unit of Use]

FDA Product Code

• KME: Bedding, Disposable, Medical

Sterilization

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

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