Ascom SW000466

GUDID 17350088671273

Ascom (Sweden) AB

Alarm application software

• Primary Device ID: 17350088671273
• NIH Device Record Key: fc55c17e-1c0c-487a-86cc-b16b6212e99a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascom
• Version Model Number: Unite Connect for Clinical Systems
• Catalog Number: SW000466
• Company DUNS: 356107490
• Company Name: Ascom (Sweden) AB
• 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: true
• 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	17350088671273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180566

FDA Product Code

• MSX: System, Network And Communication, Physiological Monitors

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: 2019-12-09
• Device Publish Date: 2019-11-29

On-Brand Devices [Ascom]

• 17350088670610: TELLIGENCE BRIDGE SOFTWARE V5.1
• 17350088670603: TELLIGENCE BRIDGE SOFTWARE V5.0
• 17350088670368: TELLIGENCE BRIDGE SOFTWARE V4.1
• 17350088670429: Unite View
• 17350088670375: Unite Connect for Nurse Call
• 17350088670351: WALL DISPLAY - NURSE CONSOLE WALL DISPLAY
• 17350088670344: TABLE DISPLAY - NURSE CONSOLE DESKTOP DISPLAY
• 17350088670337: EMERG. CALL SWITCH
• 17350088670320: VOIP COLORTOUCH STAFF STATION
• 17350088670313: DELUXE DUAL PAIENT STATION
• 17350088670306: STANDARD DUAL PATIENT STATION 3K
• 17350088670290: STANDARD DUAL PATIENT STATION
• 17350088670283: DELUXE SGL. PATIENT. STATION
• 17350088670276: STANDARD SGL. PATIENT STATION 3K
• 17350088670269: STANDARD SGL. PATIENT STATION
• 17350088670252: ROOM PRESENCE
• 17350088670245: ROOM LAVATORY
• 17350088670238: REMOTE CANCEL STATION
• 17350088670221: STAFF EMERGENCY
• 17350088670214: CODE BLUE
• 17350088670207: CALL STATION WITH RELAY
• 17350088670191: CALL STATION WITH INPUT
• 17350088670184: PAGE ADAPTER STATION
• 17350088670177: 8 PORT SWITCH
• 17350088670160: STAFF/DUTY STATION
• 17350088670153: STAFF CONSOLE
• 17350088670146: ZONE LIGHT
• 17350088670139: CORRIDOR LIGHT 4-SECTION
• 17350088670122: CORRIDOR LIGHT 2-SECTION
• 17350088670115: CORRIDOR LIGHT- SGL. RED
• 17350088670108: CALL CORD STATION
• 17350088670092: CALL CORD SGL. PATIENT STATION
• 17350088670085: SINGLE 37-PIN BED RECEPTACLE
• 17350088670078: ISOLATED DUAL AUX
• 17350088670061: ROOM DUAL AUX.
• 17350088670054: ANNUNCIATOR
• 17350088670047: DUAL 37-PIN BED RECEPTACLE
• 17350088670023: STATION GATEWAY II
• 17350088670016: Cardiomax
• 17350088670009: Mobile Monitoring Gateway (MMG)
• 17350088671167: TELLIGENCE BRIDGE SOFTWARE V6.1
• 17350088671129: TABLE DISPLAY V2
• 17350088671105: Wall Display V2 US
• 17350088671075: Speech Module US
• 17350088671068: Patient Station
• 17350088671044: Customizable Pull Cord, US
• 17350088671020: Customizable Lavatory Audio Pull Cord US
• 17350088671013: Isolated AUX Inputs US
• 17350088670863: Customizable Button US
• 17350088670849: 37 Pin Bed Conn, US