AccessGUDID - DEVICE: Tactical Cric Kit (00857048006026)

GUDID

Device Identifier (DI) Information

Brand Name: Tactical Cric Kit
Version or Model: Version 2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HHTCK01
Company Name: H&H MEDICAL CORPORATION

Primary DI Number: 00857048006026
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 072656713 *Terms of Use

Device Description: One time use non-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?
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: No
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: 0.85 Inch
Width: 3.35 Inch
Length: 8.0 Inch

Device Record Status

Public Device Record Key: f13acf1a-566d-4cb4-9a44-233d51919fa0
Public Version Date: April 01, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016