Medviron Bassinet

Basic Information

• Brand Name: Medviron Bassinet
• Primary DI: 10851477007019
• Version / Model: Guardian Bassinet
• Catalog Number: M11-0000-0000
• Company Name: MEDVIRON LLC
• Labeler DUNS: 079795848
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 913f66f5-fd91-466d-8e6d-ac55f0630ce9

Device Description

Medviron Guardian Bassinet - 1 Drawer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZG	Bassinet, Hospital	General Hospital	880.5145	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60920	Infant-hammock bed mattress	A foam-filled case with a central meshed/netted depression/hole designed to be placed in a cot/crib/bassinet/bed/incubator and to cradle a young infant during sleep/rest, and can used for phototherapy, transportation and burns patients. It is available in various shapes and sizes and is not intended to be placed on an existing mattress. The breathable netting is intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and hyperthermia. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10851477007019	GS1

Customer Contacts

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