NA

Basic Information

• Brand Name: NA
• Primary DI: 04046964317613
• Version / Model: 622310
• Catalog Number: 622310
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2021-07-30
• Public Version Status: Update
• Public Device Record Key: e1f183b9-56ba-4334-9b33-ca0008e0ffbe
• Distribution End Date: 2021-07-29

Device Description

HP10-FM 10" HP INJECTION LINE

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: No
• 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
DXT	INJECTOR AND SYRINGE, ANGIOGRAPHIC	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44685	Radiographic procedure tubing	A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964317613	GS1
Unit of Use	04046964317583	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius