Flexichamber

GUDID 00032359490201

DEMO UNIT

CERECOR INC.

Medicine chamber spacer, reusable

• Primary Device ID: 00032359490201
• NIH Device Record Key: adb5ed3e-8175-48a2-a5a0-7cddf7a0451e
• Commercial Distribution Discontinuation: 2020-06-29
• Commercial Distribution Status: Not 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	00032359490201 [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: 2020-06-30
• Device Publish Date: 2019-06-28

On-Brand Devices [Flexichamber]

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