MEDLINE

Basic Information

• Brand Name: MEDLINE
• Primary DI: 10193489110944
• Version / Model: DYNDH1645
• Catalog Number: DYNDH1645
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-05
• Public Version: 1
• Public Version Date: 2021-07-13
• Public Version Status: New
• Public Device Record Key: 8df102f6-4c6c-487f-82fd-77daef6a2d88

Device Description

CHEMO LUMBAR PUNCTURE TRAY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• 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
PWY	Lumbar puncture tray (adult & pediatric)	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12404	Lumbar puncture kit	A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20193489110941	GS1	CASE	6	In Commercial Distribution
Primary	10193489110944	GS1

Customer Contacts

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