In-Check 3109831

GUDID 05023323000804

IN-CHECK M

CLEMENT CLARKE INTERNATIONAL LIMITED

Incentive spirometer

• Primary Device ID: 05023323000804
• NIH Device Record Key: 13477a47-d682-4bb5-8787-58ab3e929b9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In-Check
• Version Model Number: 3109831
• Catalog Number: 3109831
• Company DUNS: 216155952
• Company Name: CLEMENT CLARKE INTERNATIONAL LIMITED
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05023323000804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980960

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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: 2016-09-07

On-Brand Devices [In-Check]

• 05023323001177: IN-CHECK DIAL PIFM INFO SCALE
• 05023323001153: IN-CHECK DIAL ATM (INFO)
• 05023323001146: IN-CHECK ORAL ATM
• 05023323000897: IN-CHECK DIAL G16
• 05023323000804: IN-CHECK M
• 05023323000408: IN-CHECK PFM (ORAL)
• 05023323000361: IN-CHECK PFM NASAL MED MASK
• 05023323000354: IN-CHECK DIAL 6 T&S