Model: 30-08-447-1
DI: 04250105630770
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
n.a.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
476ff1a3-b968-4b8f-a3e7-7426442e7020
Distribution Status:
In Commercial Distribution
DUNS Number:
324869601
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
14250105630777
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
04250105630770
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
04250105630770
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
04250105629736
Item #3 - Device ID Type:
Previous
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 45926
Name: Cricothyrotomy kit, single-use
Definition:
A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.
FDA Product Codes
BWC
Needle, Emergency Airway
JOH
Tube Tracheostomy And Tube Cuff
Premarket Submissions
Submission Number:
K200190
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Keep dry, Keep away from sunlight and heat