Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10197344008261
• Version / Model: DYNDTB1603
• Catalog Number: DYNDTB1603
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-23
• Public Version: 1
• Public Version Date: 2023-10-31
• Public Version Status: New
• Public Device Record Key: 855ac36f-a87b-469d-b701-56d9065f2957

Device Description

IV EXT SET,60,2.0ML, M/F LUERLOCK,CLAMP

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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60822	Medication transfer needle, filtering/vented	A slender, rigid, sharp or blunt, dual-lumen tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20197344008268	GS1	CS	100	In Commercial Distribution
Primary	10197344008261	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210381	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight, Keep dry, Keep product upright, Protect from freezing, Avoid excessive heat.