X-Series

GUDID 00850015266423

X-Small 10-20 Single-Use Strip Kit (Qty 2)

ADVANCED BRAIN MONITORING, INC.

Patient monitoring system module, electroencephalographic

• Primary Device ID: 00850015266423
• NIH Device Record Key: e5887cf1-04fb-41a7-ad32-a9463f7264eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Series
• Version Model Number: XS30-4210.2
• Company DUNS: 969842715
• Company Name: ADVANCED BRAIN MONITORING, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius
• Handling Environment Temperature: Between 7 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015266423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131383

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

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: 2022-07-06
• Device Publish Date: 2022-06-28

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• 00851113007888: X10 Disposable Sensor Kit
• 00851113007871: Disposable AgCl Sensors
• 00851113007864: External Battery Custom Cable Kit X10, X24
• 00851113007857: X10 Stat Device Kit (PAN 1026)
• 00851113007840: X24 Stat Device kit - Dongle (PAN 1026)
• 00851113007345: X24 Stat Device Kit - ESU
• 00851113007819: Medium Strip Kit
• 00851113007802: Small Strip Kit
• 00851113007796: X-Small Strip Kit
• 00851113007628: X24 Stat Device Kit - ESU
• 00851113007611: X10 Stat Device Kit
• 00851113007697: X10 Disposable Sensor Kit
• 00851113007680: 10-20 Medium Strip Kit
• 00851113007673: 10-20 Small Strip Kit
• 00851113007666: 10-20 X-Small Strip Kit
• 00851113007659: Medium Strip Kit
• 00851113007642: Small Strip Kit
• 00851113007635: X-Small Strip Kit
• 00851113007604: Linked Mastoid Cable Kit
• 00851113007598: Device Neoprene Strap
• 00851113007512: X24 Disposable Sensor Kit
• 00851113007505: 10-20 Strip Kit Medium
• 00851113007499: 10-20 Strip Kit Small
• 00851113007482: 10-20 Strip Kit X-Small
• 00851113007406: External Syncing Unit - Multi-Channel Kit
• 00851113007468: X-Series Dual Lead Cable 20" Kit
• 00851113007451: Synapse Cream Kit
• 00851113007444: EEG Foam Kit
• 00851113007420: External Battery USB Custom Cable
• 00851113007413: Linked Mastoid Cable Kit
• 10851113007366: OSFA Strap
• 00851113007352: Headset Neoprene Strap
• 00850015266348: X24 Stat System Kit Clinical
• 00850015266331: Medium 10-20 Single-Use Strip Kit (Qty 5)
• 00850015266324: Small 10-20 Single-Use Strip Kit (Qty 5)
• 00850015266317: Medium 10-20 Single-Use Strip Kit
• 00850015266300: Small 10-20 Single-Use Strip Kit
• 00850015266294: Medium 10-20 Single-Use Strip
• 00850015266287: Small 10-20 Single-Use Strip
• 00850015266409: Disposable Foam Sensors (Qty 252)
• 00850015266423: X-Small 10-20 Single-Use Strip Kit (Qty 2)
• 00850015266416: X-Small 10-20 Single-Use Strip
• 00850015266652: X-Small 10-20 Single-Use Strip Kit (Qty 2 No Sensors)
• 00850015266645: Medium 10-20 Single-Use Strip Kit (No Sensors)
• 00850015266638: Small 10-20 Single-Use Strip Kit (No Sensors)
• 00850015266614: Single-Use Strip Sensor Kit
• 00850015266249: X24 LE Stat Device Kit Clinical