PINNACLE®

Basic Information

• Brand Name: PINNACLE®
• Primary DI: 04046964201349
• Version / Model: 2112397
• Catalog Number: 2112397
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-09-04
• Public Version Status: Update
• Public Device Record Key: 58f43b1e-5755-4f97-b2ea-f42db16edded

Device Description

PINNACLE® TPN Bag Tamper Resistant Clamps, 1 L or larger

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
40589	Medical tubing clip/clamp, temporary, non-calibrated, single-use	A manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04046964201356	GS1	Carton	10	In Commercial Distribution
Primary	04046964201349	GS1
Unit of Use	04046964245220	GS1

Customer Contacts

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