Simplified Cricothyrotomy Kit HHSCK01-EA

GUDID M689HHSCK01EA020

Contains the following items: (1) Disposable Scalpel #10 Blade (1) 6.0 ID Airway with Cuff and Flange (1) 10cc Transparent Syringe (1) News Tracheal Hook (1) Trach Tube Holder

Safeguard US Operating, LLC

Cricothyrotome, single-use
Primary Device IDM689HHSCK01EA020
NIH Device Record Key72f08696-ad28-4038-bf24-8d28a68349bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplified Cricothyrotomy Kit
Version Model Number02
Catalog NumberHHSCK01-EA
Company DUNS118492643
Company NameSafeguard US Operating, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com
Phone855-428-6074
Emailfulfillment@combatmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM689HHSCK01EA020 [Primary]

FDA Product Code

OGPCricothyrotomy Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-18
Device Publish Date2022-08-10

Devices Manufactured by Safeguard US Operating, LLC

M6898444601180 - Mojo Multi Mission - Advanced2025-04-18 The Mojo® Multi-Mission Aid Bag is two medic bags in one. A main bag with 2,645 in3 of interior space designed and stocked to c
M68984493090 - Mojo Direct Action Bag - Intermediate2025-04-18 The Mojo® Direct Action Aid Bag strikes the balance between smaller Combat Lifesaver bags and bulkier advanced care bags. This
M68983301070 - Mojo First Responder - Basic2025-04-11 The Mojo® First Responder Bag is a lightweight, highly capable kit that was developed to have the smallest possible cube while
M68983323090 - Mojo Combat Lifesaver Bag - Intermediate2025-04-11 The Mojo® Combat Lifesaver Bag uses MARCH™ medical gear in a user friendly, color-coded trauma treatment system distinctly pa
M68984441110 - Mojo Multi Mission Bag - Basic2025-04-11 The Mojo® Multi-Mission Aid Bag is two medic bags in one. A main bag with 2,645 in3 of interior space designed and stocked to c
M68984443110 - Mojo Multi Mission Bag - Intermediate2025-04-11 The Mojo® Multi-Mission Aid Bag is two medic bags in one. A main bag with 2,645 in3 of interior space designed and stocked to c
M68920510080 - Sentinel Chest Trauma Kit2025-04-10 The Sentinel® Chest Trauma Kit is a comprehensive set of products that deliver an enhanced level of user confidence and improve
M68932700070 - BATTLE BANDAGE2025-04-03 The MARCH™ Battle Bandage® is the transparent compression bandage that exceeds the capabilities of traditional bandages and e

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.