H&H Simplified Cric Kit

Basic Information

• Brand Name: H&H Simplified Cric Kit
• Primary DI: 00857048006491
• Version / Model: Version 1
• Catalog Number: HHSCK01
• Company Name: H&H MEDICAL CORPORATION
• Labeler DUNS: 072656713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-04
• Public Version: 1
• Public Version Date: 2020-09-14
• Public Version Status: New
• Public Device Record Key: fd63a890-86c9-42c2-88aa-7bc459dc4798

Device Description

H&H Simplified Cric Kit, a one time use sterile emergency airway kit for opening an airway through the cricoid membrane.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGP	Cricothyrotomy Kit	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45926	Cricothyrotomy kit, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857048006491	GS1
Package	10857048006498	GS1	Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	1.75	Inch
Width	4.0	Inch
Length	9.25	Inch