Medichoice

Basic Information

• Brand Name: Medichoice
• Primary DI: 10885632114847
• Version / Model: LPT648
• Company Name: OWENS & MINOR DISTRIBUTION, INC.
• Labeler DUNS: 007941230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fdff0011-f9c5-4c41-a40b-ea89d59f7514

Device Description

X Rx Tray Lumbar Puncture With Manometer Latex-Free Sterile MediChoice

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
FMJ	MANOMETER, SPINAL-FLUID	General Hospital	880.2500	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	50885632114845	GS1		10	In Commercial Distribution
Primary	10885632114847	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid Freezing and Excessive Heat
• Type: Special Storage Condition, Specify