MedStream

Basic Information

• Brand Name: MedStream
• Primary DI: 00842472106367
• Version / Model: PC8888111950
• Catalog Number: PC88888111950
• Company Name: MEDICAL SPECIALTIES DISTRIBUTORS, LLC
• Labeler DUNS: 153608369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-19
• Public Version: 5
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 1903e75f-8ce7-4e6a-a6b4-69bb9d222bb7

Device Description

UNIVERSAL MINI PEN NDL KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
OXQ	Dressing Change Tray	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61345	Arterial/central venous catheterization support/maintenance kit, non-medicated	A collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10842472106364	GS1		100	In Commercial Distribution
Primary	00842472106367	GS1

Customer Contacts

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