BluSep™

Basic Information

• Brand Name: BluSep™
• Primary DI: 00810000529179
• Version / Model: S385
• Catalog Number: S385
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-07
• Public Version: 3
• Public Version Date: 2023-08-24
• Public Version Status: Update
• Public Device Record Key: 842d0294-229a-4b9b-9ace-5367ee1f05ca

Device Description

BluSep™

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFX	Protector, Silicate	Dental	872.6670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62375	Dental coating, bond-reduction	A non-sterile, aqueous solution intended to be applied to a prepared tooth immediately prior to application of a temporary dental restoration (e.g., resin dental inlay) to prevent formation of a strong bond between the tooth and restoration, and therefore facilitate atraumatic removal of the provisional restoration. Also referred to as a dental separating medium, it may also help prevent microbial penetration of the tooth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810000529179	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature in a dark location. Avoid freezing.
• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius