BluSep™ S385

GUDID 00810000529179

BluSep™

PARKELL, INC.

Dental coating, bond-reduction

• Primary Device ID: 00810000529179
• NIH Device Record Key: 842d0294-229a-4b9b-9ace-5367ee1f05ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluSep™
• Version Model Number: S385
• Catalog Number: S385
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark location. Avoid freezing.
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529179 [Primary]

FDA Product Code

• EFX: Protector, Silicate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-17
• Device Publish Date: 2020-02-07

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