TACTICAL CricKIT 10-0017

GUDID 00842209101344

KIT, CRICOTHYROIDOTOMY - TACTICAL CricKIT

NORTH AMERICAN RESCUE, LLC

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• Primary Device ID: 00842209101344
• NIH Device Record Key: a149a1a4-9f0b-411e-b387-0811fed0d01d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TACTICAL CricKIT
• Version Model Number: 10-0017
• Catalog Number: 10-0017
• Company DUNS: 832426782
• Company Name: NORTH AMERICAN RESCUE, LLC
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842209101344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042684

FDA Product Code

• BTO: Tube, Tracheostomy (W/Wo Connector)
• OGP: Cricothyrotomy Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-01-30
• Device Publish Date: 2016-09-17

On-Brand Devices [TACTICAL CricKIT]

• 00842209108725: KIT, TACTICAL CricKIT - CUSTOM
• 00842209101344: KIT, CRICOTHYROIDOTOMY - TACTICAL CricKIT
• 00842209109524: KIT, CRICOTHYROIDOTOMY - BOUGIE AIDED CRIC PACK-CUSTOM
• 00842209111329: KIT, CRICOTHYROTOMY - CUSTOM
• 00842209111527: KIT, CRIC KIT - CUSTOM
• 00842209117949: KIT, CRIC - CUSTOM
• 00842209122431: KIT, CRIC - CUSTOM
• 00842209129249: KIT, CRICOTHYROIDOTOMY - TACTICAL CricKIT
• 00842209129690: KIT, CRIC - SUSSEX COUNTY - EMS