Hudson RCI 1001-50

GUDID 30852417003225

Pocket Chamber Anti-Static Valved Aerosol Holding Chamber 50-Pack.

NSPIRE HEALTH, INC.

Medicine chamber spacer, reusable

• Primary Device ID: 30852417003225
• NIH Device Record Key: 0b0f6a8f-5013-4cef-b66c-fcac2643b48d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hudson RCI
• Version Model Number: Pocket Chamber
• Catalog Number: 1001-50
• Company DUNS: 184817096
• Company Name: NSPIRE HEALTH, INC.
• Device Count: 50
• 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	00852417003224 [Unit of Use]
GS1	30852417003225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993199

FDA Product Code

• CAF: Nebulizer (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: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by NSPIRE HEALTH, INC.

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