RO Class B 21 - FAC-4 KRO624-029

GUDID 00766588240299

RO Class B 21 - FAC-4

Certified Safety Manufacturing, Inc.

First aid kit, medicated

• Primary Device ID: 00766588240299
• NIH Device Record Key: c7c5d771-c1ff-4b07-91d1-e1f5fcfdff29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RO Class B 21 - FAC-4
• Version Model Number: KRO624-029
• Catalog Number: KRO624-029
• 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
• 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
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766588240299 [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: 2024-06-07
• Device Publish Date: 2024-05-30

Devices Manufactured by Certified Safety Manufacturing, Inc.

• 00766588110110 - 637 - Certi-Gauze Pads - 3"x 3" - 4/Unit: 2024-11-07 637 - Certi-Gauze Pads - 3"x 3" - 4/Unit
• 00766588110141 - 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit: 2024-11-07 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit
• 00766588110172 - 639 - Certi-Gauze Compress - 36"x 36" - 1/Unit: 2024-11-07 639 - Certi-Gauze Compress - 36"x 36" - 1/Unit
• 00766588110219 - 640 - Certi-Gauze Compress - 24"x 72" - 1/Unit: 2024-11-07 640 - Certi-Gauze Compress - 24"x 72" - 1/Unit
• 00766588110301 - 628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit: 2024-11-07 628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit
• 00766588310039 - Certi-Non Stick Pads - 2"x 3" - 25/Box: 2024-11-07 Certi-Non Stick Pads - 2"x 3" - 25/Box
• 00766588312057 - Certi-Gauze Pads - 3"x 3" - 100/Box: 2024-11-07 Certi-Gauze Pads - 3"x 3" - 100/Box
• 00766588312095 - Certi-Gauze Pads - 2"x 2" - 25/Box: 2024-11-07 Certi-Gauze Pads - 2"x 2" - 25/Box