EncoreAnywhere 1101039

GUDID 00606959053366

EncoreAnywhere - EU Instance

Respironics, Inc.

Medical equipment clinical data interfacing software

• Primary Device ID: 00606959053366
• NIH Device Record Key: c8514d64-c910-4bea-ac42-f0546244d50f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EncoreAnywhere
• Version Model Number: 2.39
• Catalog Number: 1101039
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959053366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121623

FDA Product Code

• MNT: Ventilator, continuous, minimal ventilatory support, facility use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [EncoreAnywhere]

• 00606959054837: EncoreAnywhere - Japan Instance
• 00606959054820: EncoreAnywhere - China Instance
• 00606959054813: EncoreAnywhere - EU Instance
• 00606959054806: EncoreAnywhere-North America Instance
• 00606959053380: EncoreAnywhere - Japan Instance
• 00606959053373: EncoreAnywhere - China Instance
• 00606959053366: EncoreAnywhere - EU Instance
• 00606959053359: EncoreAnywhere-North America Instance
• 00606959052284: EncoreAnywhere - Japan Instance
• 00606959052277: EncoreAnywhere - China Instance
• 00606959049987: EncoreAnywhere-China Instance
• 00606959049468: EncoreAnywhere-North America Instance
• 00606959049444: EncoreAnywhere - EU Instance
• 00606959048386: EncoreAnywhere data management system (U.S./North America)
• 00606959048379: EncoreAnywhere - JP instance
• 00606959048362: EncoreAnywhere - EU Instance
• 00606959047242: EncoreAnywhere - JP instance
• 00606959047235: EncoreAnywhere - EU Instance
• 00606959047228: EncoreAnywhere Data Management Software (U.S. - North America)
• 00606959045378: EncoreAnywhere - JP instance
• 00606959045361: EncoreAnywhere - EU Instance
• 00606959045309: EncoreAnywhere-NA Instance
• 00606959045187: EncoreAnywhere - JP instance
• 00606959045170: EncoreAnywhere - EU Instance
• 00606959045163: EncoreAnywhere-NA Instance
• 00606959042902: EncoreAnywhere Data Management Software (North American Instance)
• 00606959042896: EncoreAnywhere - JP instance
• 00606959042889: EncoreAnywhere - EU Instance
• 00606959040458: EncoreAnywhere - JP instance
• 00606959040380: EncoreAnywhere - EU Instance
• 00606959040373: EncoreAnywhere-NA Instance
• 00606959055834: EncoreAnywhere - APAC Instance
• 00606959055827: EncoreAnywhere-China Instance
• 00606959055810: EncoreAnywhere-EU Instance
• 00606959055803: EncoreAnywhere-North America Instance
• 00606959058576: EncoreAnywhere - JP instance 2.43
• 00606959058569: EncoreAnywhere - China Instance 2.43
• 00606959058552: EncoreAnywhere-NA Instance 2.43
• 00606959057050: EncoreAnywhere - JP instance
• 00606959057043: EncoreAnywhere - China Instance
• 00606959057029: EncoreAnywhere-North America Instance
• 00606959060470: EncoreAnywhere - JP Instance 2.44
• 00606959060463: EncoreAnywhere - China Instance 2.44
• 00606959060456: EncoreAnywhere-NA Instance 2.44