Able 3607000

GUDID 05023323000293

ABLE SPACER

CLEMENT CLARKE INTERNATIONAL LIMITED

Medicine chamber spacer, reusable

• Primary Device ID: 05023323000293
• NIH Device Record Key: 3b987e9b-4d80-47dd-89c2-a2a6feb373b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Able
• Version Model Number: 3607000
• Catalog Number: 3607000
• Company DUNS: 216155952
• Company Name: CLEMENT CLARKE INTERNATIONAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401279414969
• Email: twhay@ccholdingsltd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05023323000293 [Primary]

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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: 2019-06-14
• Device Publish Date: 2019-06-06

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• 05023323029973 - VentiChamber: 2024-10-15 VentiChamber + Small VC Mask
• 05023323029997 - VentiChamber: 2024-10-15 VentiChamber + Medium VC Mask
• 05023323030023 - VentiChamber: 2024-10-15 VentiChamber + Large VC Mask
• 05023323029799 - InspiraChamber®: 2024-06-06 InspiraChamber® Anti-Static Valved Holding Chamber + Small InspiraMask™
• 05023323029812 - InspiraChamber®: 2024-06-06 InspiraChamber® Anti-Static Valved Holding Chamber + Medium InspiraMask™
• 05023323029829 - InspiraChamber®: 2024-06-06 InspiraChamber® Anti-Static Valved Holding Chamber + Large InspiraMask™