ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 50801902005101
• Version / Model: IPN045605
• Catalog Number: AK-05420-P
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-27
• Public Version: 5
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 4c3320d4-4aab-4512-be7d-748ee29ec38f

Device Description

FlexTip Plus(R) Epidural Catheterization Kit for Caudal Placement

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: 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
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61911	Epidural anaesthesia set, medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40801902005104	GS1	Box	10	Not in Commercial Distribution	2021-04-15
Primary	50801902005101	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103658	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store between 20 - 25°C (68 - 77°F). Avoid freezing and excessive heat above 40°C (104°F).
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius