AccessGUDID - DEVICE: TacMed™ Surgical Airway Ki (00818630010227)

GUDID

Device Identifier (DI) Information

Brand Name: TacMed™ Surgical Airway Ki
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSAK-HC
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00818630010227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: The TacMed™ Surgical Airway Kit provides the essential items to successfully establish and secure a surgical airway in any environment. All of the necessary components are neatly vacuum-packed for easy storage and maximum accessibility. Standard Contents: 1x Tracheostomy Tube Cuffed size 6.0MM 1x #10 Disposable Scalpel 1x 3CC Syringe 1x Serpent Hook 1x Alcohol Pads 1PR Nitrile Gloves

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):	No
Over the Counter (OTC):	No
Kit:	No
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: Yes

Sterilization Method [?]
Ethylene Oxide

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: ae359393-1ca0-4e58-b5ab-5f2dd9b63af8
Public Version Date: November 16, 2020
Public Version Number: 1
DI Record Publish Date: November 06, 2020