Epimed

Basic Information

• Brand Name: Epimed
• Primary DI: 00818788021045
• Version / Model: 155-1520
• Catalog Number: 155-1520
• Company Name: EPIMED INTERNATIONAL, INC
• Labeler DUNS: 799751953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-20
• Public Version: 6
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: a00e77d0-6ba4-4140-80f8-e5f668e611b6

Device Description

Tun-L-Kath® 19g x 33.25"

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSO	CATHETER, CONDUCTION, ANESTHETIC	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal 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	10818788021042	GS1	Case	10	In Commercial Distribution
Primary	00818788021045	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K954584	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	3.2	French
Device Size Text, specify			33.25"
Length	33.25	Inch
Device Size Text, specify			19g

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit