Medichoice

Basic Information

• Brand Name: Medichoice
• Primary DI: 10885632147258
• Version / Model: PA1007C
• 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: 4
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 46d5eb25-b935-4b8a-942b-01dcbdd374c9

Device Description

Tray Port Access Gloves Not Included Tegaderm Gauze Skin Closure Tape Chloraprep No Sting Swab Mask Hand Sanitizer White Paper

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
OFF	Central venous catheter tray	Cardiovascular	870.1140	2

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	20885632147255	GS1		30	In Commercial Distribution
Primary	10885632147258	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid freezing and excessive heat