InspiraChamber Valved Holding Chamber

GUDID 10852367007065

InspiraChamber Anti-Static Valved Holding Chamber (Teleflex medical) 1001-50

INSPIRX, INC

Medicine chamber spacer, reusable

• Primary Device ID: 10852367007065
• NIH Device Record Key: 385f82ba-6c25-4576-aefb-bba479ba88d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InspiraChamber Valved Holding Chamber
• Version Model Number: 1001-50
• 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

Customer Support Contacts

• Phone: 1-888-471-4990
• Email: ronnie.toddywala@inspirxpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852367007068 [Primary]
GS1	10852367007065 [Package]; Contains: 00852367007068; Package: case [50 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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [InspiraChamber Valved Holding Chamber]

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