ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902182835
• Version / Model: IPN919187
• Catalog Number: IAK-02263
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-13
• Public Version: 3
• Public Version Date: 2023-09-06
• Public Version Status: Update
• Public Device Record Key: 4225eb03-3691-475e-8bff-3164a72ac20a

Device Description

DATASCOPE(R) 30cc & 40cc

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
DSP	System, balloon, intra-aortic and control	Cardiovascular	870.3535	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36340	Intra-aortic balloon pump	An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801902182832	GS1	Box	5	In Commercial Distribution
Primary	10801902182835	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993966	000

Device Sizes

Type	Value	Unit	Text
Length	86	Inch