RUSleeping RTS 1127363

GUDID 00606959029132

RUSleeping RTS, Model

Respironics, Inc.

Polysomnograph

• Primary Device ID: 00606959029132
• NIH Device Record Key: aef80aff-6b71-4a84-9229-9130a5ed5192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RUSleeping RTS
• Version Model Number: RUSLEEPING RTS
• Catalog Number: 1127363
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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	00606959029132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022294

FDA Product Code

• MNR: VENTILATORY EFFORT RECORDER

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: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [RUSleeping RTS]

• 00606959020566: RUSleeping RTS, International
• 00606959020405: RUSleeping RTS System
• 00606959029156: RUSleeping RTS, China Model
• 00606959029149: RUSleeping RTS, International Model
• 00606959029132: RUSleeping RTS, Model
• 00606959029125: RUSleeping RTS, China