B1X5 Software Upgrade

GUDID 00840682141291

B125/B105 V1.5 SW PACK (USB) - MD

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00840682141291
• NIH Device Record Key: dd097498-4601-49da-a4c0-3adcd26e51e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B1X5 Software Upgrade
• Version Model Number: V1.5
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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: 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	00840682141291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201941

FDA Product Code

• OLW: Index-generating electroencephalograph software

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-11-18

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 00840682124669 - NA: 2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 2.4M
• 00840682124683 - NA: 2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M
• 00195278421449 - CAM: 2025-04-15 CAM 14 - MDR
• 00195278421456 - CAM: 2025-04-15 CAM HD - MDR
• 00195278364661 - CardioSoft: 2025-04-02 CARDIOSOFT V7.0 SP7.2
• 00195278403643 - CASE: 2025-04-02 CASE V7.0
• 00195278617644 - CASE: 2025-04-02 CASE V7 GENERIC ATO
• 00840682144322 - MAC: 2025-03-21 MAC 7