ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902145830
• Version / Model: IPN039807
• Catalog Number: ASK-00376-JHH
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-09
• Public Version: 1
• Public Version Date: 2019-07-17
• Public Version Status: New
• Public Device Record Key: a42b12b0-681a-41e6-b55a-abfbef8687f8

Device Description

Large Volume Abdominal Paracentesis Kit with Sharps Safety Features

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
JOL	CATHETER AND TIP, SUCTION	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47797	Pleural/peritoneal drainage catheterization kit	A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801902145837	GS1	Case	6	In Commercial Distribution
Primary	10801902145830	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French

Storage Conditions

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