PINNACLE®

Basic Information

• Brand Name: PINNACLE®
• Primary DI: 04046964201011
• Version / Model: 2112408
• Catalog Number: 2112408
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 7
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2021-02-17
• Public Version Status: Update
• Public Device Record Key: fe064cf4-2e96-4219-bd43-a7511f2faac7

Device Description

PINNACLE® Dual Chamber Mixing Container, EVA Formulation, 4000 mL (3500+500)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPE	CONTAINER, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04046964201028	GS1	Carton	4	In Commercial Distribution
Primary	04046964201011	GS1
Unit of Use	04046964245251	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]