16M - FairPoint - Metal K604-095

GUDID 00766588040950

16M - FairPoint - Metal

Certified Safety Manufacturing, Inc.

First aid kit, medicated

• Primary Device ID: 00766588040950
• NIH Device Record Key: 792f2e20-c4bc-4201-8833-15122780921a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16M - FairPoint - Metal
• Version Model Number: K604-095
• Catalog Number: K604-095
• Company DUNS: 788460483
• Company Name: Certified Safety Manufacturing, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766588040950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940249

FDA Product Code

• LRR: First Aid Kit with drug

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: 2022-12-08
• Device Publish Date: 2022-11-30

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• 00766588220109 - 36M - Class B 21 White Cap - 36 Metal: 2024-09-18 36M - Class B 21 White Cap - 36 Metal