AccessGUDID - DEVICE: Emergency Cric Kit (M689HHECT01040)

GUDID

Device Identifier (DI) Information

Brand Name: Emergency Cric Kit
Version or Model: 04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HHECT01
Company Name: Safeguard US Operating, LLC

Primary DI Number: M689HHECT01040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: Emergency Cric Kit is designed around a bougie assisted method that has everything trauma personnel will need to perform an extreme emergency cricothyrotomy.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11052	Cricothyrotome, single-use	A sterile, hand-held, manual surgical instrument intended to be used to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds 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 of the upper airway tract, and prior to tracheotomy. It is made of high-grade stainless steel and plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGP	Cricothyrotomy Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00d0b7da-2429-4b5c-892c-ef7e23be33fd
Public Version Date: December 29, 2025
Public Version Number: 1
DI Record Publish Date: December 19, 2025