Inspirachamber with InspiraMask (Large)

GUDID 00852367007013

InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit

INSPIRX, INC

Medicine chamber spacer, reusable

• Primary Device ID: 00852367007013
• NIH Device Record Key: 1f75d8ef-96b9-4932-a441-ceff33f2322d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspirachamber with InspiraMask (Large)
• Version Model Number: IC-IML-0
• Company DUNS: 967174850
• Company Name: INSPIRX, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852367007013 [Primary]
GS1	10852367007010 [Package]; Package: [10 Units]; 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-18

Devices Manufactured by INSPIRX, INC

• 10852367007072 - InspiraChamber Valved Holding Chamber: 2019-12-19 InspiraChamber with SootherMask (Small) (Teleflex Medical) 1001-10SS
• 10852367007126 - InspiraChamber Valved Holding Chamber: 2019-12-19 InspiraChamber with InspiraMask (Large) (Teleflex Medical) 1001-10L
• 10852367007133 - InspiraChamber Valved Holding Chamber: 2019-12-19 InspiraChamber with SootherMask (Medium) (Teleflex Medical) 1001-10SM
• 10852367007157 - InspiraChamber Valved Holding Chamber: 2019-12-19 InspiraChamber with InspiraMask (Medium) (Teleflex Medical) 1001-10M
• 10852367007164 - InspiraChamber Valved Holding Chamber: 2019-12-19 InspiraChamber with InspiraMask (Small) (Teleflex Medical) 1001-10S
• 10852367007058 - InspiraChamber Valved Holding Chamber: 2019-07-24 InspiraChamber Anti-Static Valved Holding Chamber (Teleflex Medical) 1001-10
• 10852367007065 - InspiraChamber Valved Holding Chamber: 2019-07-24 InspiraChamber Anti-Static Valved Holding Chamber (Teleflex medical) 1001-50
• 10852367007003 - InspiraChamber Valved Holding Chamber: 2018-03-29 InspiraChamber Anti-Static Valved Holding Chamber- Hospital Unit