APEX™ AX1000

GUDID 04046955048502

APEX® Compounding System

B. BRAUN MEDICAL INC.

Intravenous solution compounder

• Primary Device ID: 04046955048502
• NIH Device Record Key: c036674c-4ffd-4789-8fa2-d3c52f615e49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX™
• Version Model Number: AX1000
• Catalog Number: AX1000
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbra
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955048502 [Primary]

FDA Product Code

• NEP: SYSTEM/DEVICE, PHARMACY COMPOUNDING

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: 2020-07-07
• Device Publish Date: 2016-09-23

On-Brand Devices [APEX™]

• 04046964801082: APEX, CONTROL MODULE - TPN MANAGER
• 04046964688560: Universal Spikes (Singles)
• 04046964669729: Universal Spikes (5-Packs)
• 04046964548413: 2000 mL Calibration Container
• 04046964539312: EVA Dual-Chamber Final Containers 400 0 mL
• 04046964539299: EVA Dual-Chamber Final Containers 300 0 mL
• 04046964539275: EVA Dual-Chamber Final Containers 150 0 mL
• 04046964539251: EVA Single-Chamber Final Containers 4000 mL
• 04046964539237: EVA Single-Chamber Final Containers 3000 mL
• 04046964539213: EVA Single-Chamber Final Containers 2000 mL
• 04046964539190: EVA Single-Chamber Final Containers 1000 mL
• 04046964539176: EVA Single-Chamber Final Containers 250 mL
• 04046964539138: EVA Single-Chamber Final Containers 500 mL
• 04046955048502: APEX® Compounding System
• 04046964958151: APEX, CONTROL MODULE, CAPS - ASSET
• 04046964958144: APEX, CONTROL MODULE, TPN MGR - ASSET
• 04046964958137: APEX, CONTROL MODULE - ASSET
• 04046964801068: APEX, CONTROL MODULE
• 04046964801051: APEX, PUMP MODULE
• 04046964801044: APEX, LOAD CELL MODULE