Flexichamber 901-100

GUDID 00313551000055

Holding Chambers, Direct Patient Interface

AVADEL PHARMACEUTICALS (USA), INC.

Medicine chamber spacer, reusable

• Primary Device ID: 00313551000055
• NIH Device Record Key: 44568143-9818-4f99-8a1a-4bea9ed7e91a
• Commercial Distribution Discontinuation: 2018-11-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Flexichamber
• Version Model Number: Anti-Static Valved Collapsible Holding Chamber
• Catalog Number: 901-100
• Company DUNS: 169886244
• Company Name: AVADEL PHARMACEUTICALS (USA), 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00313551000055 [Primary]

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: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2017-03-09

On-Brand Devices [Flexichamber]

• 00313551000055: Holding Chambers, Direct Patient Interface
• 00313551000017: DEMO UNIT