BG 323 Pump System

GUDID B101100516PXS0

Pump, battery 3600mAh, wall charger, operators manual, PCA Bolus IFU

CME AMERICA LLC

General-purpose infusion pump, line-powered

• Primary Device ID: B101100516PXS0
• NIH Device Record Key: 38b66182-3be7-4762-9b2c-bbfbd7ac80cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BG 323 Pump System
• Version Model Number: 100-516PXS
• Company DUNS: 002125419
• Company Name: CME AMERICA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B101100516PXS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042696

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [BG 323 Pump System]

• B101100517PXS0: pump, battery 1800mHh, wall charger, Operator's Manual
• B101100516PXS0: Pump, battery 3600mAh, wall charger, operators manual, PCA Bolus IFU
• B101100510PXSI0: Pump, Battery 1800mAh, Pole Mount Charger, Power Cord, Operator's Manual