K-Pack II

Basic Information

• Brand Name: K-Pack II
• Primary DI: 05413206033201
• Version / Model: KN-2516RB05
• Catalog Number: KN-2516RB05
• Company Name: Terumo Europe NV
• Labeler DUNS: 370193559
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 6
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: f9cb87d2-899a-4eda-87c6-b547622d9de6

Device Description

K-Pack II Needle

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: 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: Yes
• 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55413206033206	GS1	Carton	5000	In Commercial Distribution
Primary	05413206033201	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984576	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Needle Length: 0.625 Inch
Needle Gauge	25	Gauge
Device Size Text, specify			Needle Length: 16 Millimeter
Device Size Text, specify			Needle Outer Diameter: 0.5 Millimeter
Device Size Text, specify			Thin wall

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Keep dry.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius