PINNACLE® 601184

GUDID 04046964957437

FINAL ASSEMBLY - PUMP MODULE

B. BRAUN MEDICAL INC.

Intravenous solution compounder

• Primary Device ID: 04046964957437
• NIH Device Record Key: a13bfda6-cc00-4a72-841b-9abfd8479131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINNACLE®
• Version Model Number: 601184
• Catalog Number: 601184
• 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: 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(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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964957437 [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: 2023-09-06
• Device Publish Date: 2016-09-23

On-Brand Devices [PINNACLE®]

• 04046955308569: PC5000, TPN CONTROL MODULE, WIN-10
• 04046955308552: PC5000, SCDM CONTROL MODULE, WIN-10
• 04046955334605: TPN MGR CNTRL MOD WIN-10, ASSET
• 04046964201073: PINNACLE® Dual Chamber Bag Fill Set
• 04046964200991: PINNACLE® Dual Chamber Mixing Container, EVA Formulation, 3000 mL (2500+500)
• 04046964200717: PINNACLE® Single Chamb er Mixing Container, EVA Formulation, 2000 mL
• 04046964447198: PINNACLE® TPN Management System
• 04046964201356: PINNACLE® TPN Bag Tamper Resistant Clamps, 1 L or larger
• 04046964201141: PINNACLE® High Flow Y-Adapter
• 04046964200472: PINNACLE® 9-Lead Non-Vented Transfer Set
• 04046964200373: PINNACLE® 6-Lead Non-Vented Transfer Set
• 04046964200311: PINNACLE® 9-Lead Vented Transfer Set
• 04046964200229: PINNACLE® 6-Lead Vented Transfer Set
• 04046964200564: PINNACLE® Single Chamber Mixing Container, EVA Formulation, 250 mL
• 04046964201028: PINNACLE® Dual Chamber Mixing Container, EVA Formulation, 4000 mL (3500+500)
• 04046964200908: PINNACLE® Dual Chamber Mixing Container, EVA Formulation, 1500 mL (1250+250)
• 04046964200625: PINNACLE® Single Chamber Mixing Container, EVA Formulation, 500 mL
• 04046955772780: SCB 1000ML EVA MIXING CONT. SINGLE PACK
• 04046955772773: SCB 500ML EVA MIXING CONT. SINGLE PACK
• 04046955772315: SCB 250ML EVA MIXING CONT. SINGLE PACK
• 04046955770595: DCB PINNACLE 4000ML SINGLE PACK
• 04046955770588: DCB PINNACLE 3000ML SINGLE PACK
• 04046955770571: DCB PINNACLE 1500ML SINGLE PACK
• 04046955770564: SCB 4000ML EVA MIXING CONT. SINGLE PACK
• 04046955738229: SCB 3000ML EVA MIXING CONT. SINGLE PACK
• 04046955738212: SCB 2000ML EVA MIXING CONT. SINGLE PACK
• 04046964957604: CONTROL MODULE, TPN MANAGER - ASSET
• 04046964957451: FINAL ASSY, CONTROL MODULE, TPN MANAGER
• 04046964957444: CONTROL MODULE, PINNACLE
• 04046964957499: CONTROL MODULE, PINNACLE - ASSET
• 04046964957482: FINAL ASSEMBLY PUMP MODULE - ASSET
• 04046964957437: FINAL ASSEMBLY - PUMP MODULE