In-Check 3109831

GUDID 05023323000804

IN-CHECK M

CLEMENT CLARKE INTERNATIONAL LIMITED

Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer 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