ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 20801902036616
• Version / Model: IPN046555
• Catalog Number: MTO-03000-VM
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 5
• Public Version Date: 2021-01-18
• Public Version Status: Update
• Public Device Record Key: 5523cfb1-dba7-4eff-abba-86aff531c6e0

Device Description

Epidural Anesthesia Kit (No Catheter Included)

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
BSO	CATHETER, CONDUCTION, ANESTHETIC	Anesthesiology	868.5120	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	10801902036619	GS1	Box	10	In Commercial Distribution
Primary	20801902036616	GS1
Previous	00801902036612	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140110	000

Device Sizes

Type	Value	Unit	Text
Length	8.89	Centimeter

Storage Conditions

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