Flexichamber 902-100

GUDID 00313551000017

DEMO UNIT

AVADEL PHARMACEUTICALS (USA), INC.

Medicine chamber spacer, reusable

• Primary Device ID: 00313551000017
• NIH Device Record Key: 838dfae8-91fe-4bf2-86cd-9a97a4337e1f
• 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: 902-100
• 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	00313551000000 [Primary]
GS1	00313551000017 [Package]; Contains: 00313551000000; Package: Carton Box [44 Units]; Discontinued: 2018-11-07; Not in Commercial Distribution

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: 2016-09-19

On-Brand Devices [Flexichamber]

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