ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902179361
• Version / Model: IPN919009
• Catalog Number: IAH-09048
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-17
• Public Version: 2
• Public Version Date: 2024-01-10
• Public Version Status: Update
• Public Device Record Key: ad7f6cb7-fc1a-4964-9ce2-6b86e55af887

Device Description

HELIUM: HZL 105 LITER 22 16 PS

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: No
• 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: No
• 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
46097	Medical air refillable cylinder	A container designed as a refillable cylinder used to hold compressed medical air [a mixture of approximately 21% oxygen (O2) and 78% nitrogen (N2) and other inert gases] under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with medical air when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote medical air content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the air at the correct working pressure. Medical air is used for life support, therapeutic purposes and in anaesthesia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801902179368	GS1	Box	1	In Commercial Distribution
Primary	10801902179361	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060309	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 52 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store between -15 Celsius and 40 Celsius