OTS - Class B 21 Field Trauma - Hawkespack K622-002

GUDID 00766588620022

OTS - Class B 21 Field Trauma - Hawkespack

Certified Safety Manufacturing, Inc.

First aid kit, medicated

• Primary Device ID: 00766588620022
• NIH Device Record Key: ba0dd5ff-0c73-43e5-a19d-a456c97f7d3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTS - Class B 21 Field Trauma - Hawkespack
• Version Model Number: K622-002
• Catalog Number: K622-002
• 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: true
• Device Combination Product: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766588620022 [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: 2022-11-08
• Device Publish Date: 2022-10-31

Devices Manufactured by Certified Safety Manufacturing, Inc.

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• 00766588249070 - Class A 21 Assortment Pack: 2025-04-04 Class A 21 Assortment Pack
• 00766588249094 - Class A 21 Plus - 16 Poly White: 2025-04-04 Class A 21 Plus - 16 Poly White
• 00766588249186 - Class A 21 Plus - RTB 5186: 2025-04-04 Class A 21 Plus - RTB 5186
• 00766588257006 - Class A 21 Plus/CTB - 24 Poly White: 2025-04-04 Class A 21 Plus/CTB - 24 Poly White
• 00766588257013 - Class A 21 Plus/BBP - 24 Poly White: 2025-04-04 Class A 21 Plus/BBP - 24 Poly White
• 00766588257037 - Class A 21 Plus/BBP/CTB - 36 Metal: 2025-04-04 Class A 21 Plus/BBP/CTB - 36 Metal
• 00766588247045 - Heat Stress - 10 Poly White: 2025-04-01 Heat Stress - 10 Poly White