Sleepware 1121998

GUDID 00606959038943

Sleepware G3 Software Package, Japan

Respironics, Inc.

Polysomnography analyser

• Primary Device ID: 00606959038943
• NIH Device Record Key: 74bf6e79-aaf4-45ab-a24f-40b842885da3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleepware
• Version Model Number: 3.8
• Catalog Number: 1121998
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959038943 [Primary]

FDA Product Code

• OLZ: Automatic event detection software for polysomnograph with electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-11

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• 00606959004849: Sleepware G3 Software Package, English
• 00606959046955: Software, Sleepware G3 (Japan Only)
• 00606959045279: Software, Sleepware G3, Web download
• 00606959045262: Software, Sleepware G3 (Multi-Lingual)
• 00606959045255: Software, Sleepware G3 (EN)
• 00606959039049: HL7 Forwarding Service Software
• 00606959039001: Sleepware G3 Software, Web
• 00606959038967: HL7 Software for Sleepware G3, Web
• 00606959038943: Sleepware G3 Software Package, Japan