InspiraChamber Anti-static Valved Holding Chamber

GUDID 00327437024011

InspiraChamber Anti-static Valved Holding Chamber (Retail Unit)

LUPIN PHARMACEUTICALS, INC.

Medicine chamber spacer, reusable

• Primary Device ID: 00327437024011
• NIH Device Record Key: 3808aa67-723f-4e74-bdae-ec677eb3a65e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InspiraChamber Anti-static Valved Holding Chamber
• Version Model Number: IPX1024
• Company DUNS: 089153071
• Company Name: LUPIN PHARMACEUTICALS, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003992561
• Email: info@askarm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00327437024011 [Primary]
GS1	30327437024012 [Package]; Package: Shipper [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130598

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

Devices Manufactured by LUPIN PHARMACEUTICALS, INC.

• 00327437024011 - InspiraChamber Anti-static Valved Holding Chamber: 2019-09-09InspiraChamber Anti-static Valved Holding Chamber (Retail Unit)
• 00327437024011 - InspiraChamber Anti-static Valved Holding Chamber: 2019-09-09 InspiraChamber Anti-static Valved Holding Chamber (Retail Unit)
• 30327437025019 - Inspirachamber with SootherMask (small) and InspiraMask (small): 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit)
• 30327437026016 - Inspirachamber with SootherMask (medium) and InspiraMask (medium): 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (medium) and InspiraMask (medium) (Retail Unit)
• 30327437043013 - Inspirachamber with Inspiramask (Large): 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit)