Flexichamber

GUDID 00323594901011

Holding Chambers, Direct Patient Interface

CERECOR INC.

Medicine chamber spacer, reusable

• Primary Device ID: 00323594901011
• NIH Device Record Key: 15306492-44c6-4e74-b95f-5ee433a931e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexichamber
• Version Model Number: Anti-Static Valved Collapsible Holding Chamber
• Company DUNS: 968799028
• Company Name: CERECOR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00323594901011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140062

FDA Product Code

• NVP: Holding Chambers, Direct Patient Interface

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-26
• Device Publish Date: 2018-10-01

On-Brand Devices [Flexichamber]

• 00323594901011: Holding Chambers, Direct Patient Interface
• 00032359490201: DEMO UNIT