AccessGUDID - DEVICE: H&H Emergency Cricothyrotomy Kit (00857048006002)

GUDID

Device Identifier (DI) Information

Brand Name: H&H Emergency Cricothyrotomy Kit
Version or Model: Version 5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HHECT01
Company Name: H&H MEDICAL CORPORATION

Primary DI Number: 00857048006002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072656713 *Terms of Use

Device Description: One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.

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?
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.	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: Yes 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
Height: 1.75 Inch
Width: 4.0 Inch
Length: 9.25 Inch

Device Record Status

Public Device Record Key: dc61bcec-62d4-427b-9388-0ca0e7aad755
Public Version Date: April 01, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016