Alaris™ Pump Module, Model 8100 10938662

GUDID 10885403211423

Alaris™ Pump Module, Model 8100 v8.5.29.0

CAREFUSION 303, INC.

Bedside infusion pump, single-channel

• Primary Device ID: 10885403211423
• NIH Device Record Key: 1217f26a-627b-4580-97b0-f74e19b16eba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris™ Pump Module, Model 8100
• Version Model Number: 8100
• Catalog Number: 10938662
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, 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: true
• 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

Customer Support Contacts

• Phone: +1(844)823-5433
• Email: ProductComplaints@bd.com
• Phone: +1(844)823-5433
• Email: ProductComplaints@bd.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403211423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133532

FDA Product Code

• FRN: Pump, infusion

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: 2025-12-29
• Device Publish Date: 2025-12-19

Devices Manufactured by CAREFUSION 303, INC.

• 10885403211423 - Alaris™ Pump Module, Model 8100: 2025-12-29Alaris™ Pump Module, Model 8100 v8.5.29.0
• 10885403211423 - Alaris™ Pump Module, Model 8100: 2025-12-29 Alaris™ Pump Module, Model 8100 v8.5.29.0
• 10885403423208 - Alaris™ Syringe Module, Model 8110: 2025-12-29 Alaris™ Syringe Module, Model 8110 v8.5.6 R
• 10885403533235 - BD Pyxis: 2025-11-24 BD Pyxis MedStation ES (Auxiliary)
• 10885403533242 - Pyxis: 2025-11-24 Pyxis Anesthesia System ES
• 10885403520761 - BD Alaris™ ETCO2 Module, Model 8300: 2025-09-18 BD Alaris™ ETCO2 Module, Model 8300 v12.6
• 10885403521836 - Pyxis Pro MedStation: 2025-08-11 Pyxis Pro MedStation Dispensing System cabinet, table and tray, anesthesia
• 10885403521966 - Pyxis Pro MedStation: 2025-08-11 Pyxis Pro MedStation Dispensing System cabinet, table and tray, anesthesia
• 10885403237867 - MaxGuard: 2025-08-01 MaxGuard bag access spike