VueBlu

Basic Information

• Brand Name: VueBlu
• Primary DI: 05391530190527
• Version / Model: 5000311
• Company Name: COSMO SPA
• Labeler DUNS: 630431955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-21
• Public Version: 1
• Public Version Date: 2023-07-31
• Public Version Status: New
• Public Device Record Key: e0dd5eb9-d40f-4e2d-af0d-3d4addca835f

Device Description

Individual 10mL Vial of Methylene Blue Solution 0.5%

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
NBG	Marker, Colon	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61248	Operative procedure tissue/fluid stain	A solution (e.g., methylene blue, amylase-degraded microspheres) intended to be used as an in vivo tissue- or fluid-staining visualization aid during and/or after open or minimally-invasive surgery, particularly for delineation of tissues and operative pieces, seal testing sutures, and/or detection of leaks (e.g., pancreatic juice) and fistulas. Exact usage depends on the requirements of the surgeon and the surgical procedure performed. It is typically supplied in a glass vial or syringe. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391530190541	GS1	Folding Box	5	In Commercial Distribution
Primary	05391530190527	GS1
Package	05391530190558	GS1	Inner Case	96	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius