ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 30801902093913
• Version / Model: IPN000328
• Catalog Number: IAP-0500X
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 11
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: bb4b1600-23cc-406d-8cec-7a00cbb3be95

Device Description

AutoCAT2WAVE(R) IABP, Refurbished

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
Primary	30801902093913	GS1
Direct Marking	00801902093912	GS1

Premarket Submissions

Submission Number	Supplement Number
K060309	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 80 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Store between -15 - 40°C (5 - 104°F)