Spacelabs 96181

GUDID 10841522129216

SMART ALARM INTERFACE (SAI)

SPACELABS HEALTHCARE (WASHINGTON), INC

Medical equipment clinical data interfacing software

• Primary Device ID: 10841522129216
• NIH Device Record Key: 03a9ff14-fead-4f75-8734-548ce2000c77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spacelabs
• Version Model Number: Smart Alarm Interface (SAI)
• Catalog Number: 96181
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), 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	10841522129216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193421

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: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [Spacelabs]

• 10841522113093: CAPNO MODULE,92517
• 10841522113086: CAPNO POD,92516
• 10841522108785: OPTION, NELLCOR OXIMAX SPO2, REFURBISHED
• 10841522106279: MODULE,EEG/EMG,32MB
• 10841522125584: LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE
• 10841522129629: CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
• 10841522129612: CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
• 10841522129605: CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
• 10841522129582: CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
• 10841522129216: SMART ALARM INTERFACE (SAI)