CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10888439062823
• Version / Model: SMY32MYNM1
• Catalog Number: SMY32MYNM1
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-11
• Public Version: 3
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: b3dfe29d-0df7-4984-98fd-29d77a07fa9f

Device Description

MYELOGRAM

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: Yes
• 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
OIP	Radiology-diagnostic kit	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35199	Myelography kit	A collection of devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. It is also referred to as myelogram tray and typically includes a needle, syringe, tubing, contrast medium, and other consumable items. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50888439062821	GS1	CASE	10	In Commercial Distribution
Primary	10888439062823	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius