NA

Basic Information

• Brand Name: NA
• Primary DI: 04046964316982
• Version / Model: 622010
• Catalog Number: 622010
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: dfc51628-a5be-4ee3-9207-ed6e7357a5f5

Device Description

CMS100 CMS SPIKE ASSY VENTED

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
IZI	System, x-ray, angiographic	Radiology	892.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964316982	GS1
Unit of Use	04046964316951	GS1

Customer Contacts

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