AccessGUDID - DEVICE: Easy Carry Trauma Kit (M689HHECTK010)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Carry Trauma Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HHECTK-01
Company Name: Safeguard US Operating, LLC

Primary DI Number: M689HHECTK010
Issuing Agency: HIBCC
Commercial Distribution End Date: June 02, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: SWAT-TORG SWAT-T Tourniquet, Orange 30-212 MARCH Celox Rapid B-CON 3"x2' OTC HVS01 H*VENT Vented Chest Seal, Single HHMCB01 Mini-Compression Bandage (Sterile) - 4" x 6" abdominal pad GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free L01-002 2X4WHITE BLANK LABEL P88-100 Pouch, 6X12-LE Kit

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):	Yes
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?
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHW	Dressing, Compression

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 95ea93e0-abba-4655-b1ba-1a3a900ebc7e
Public Version Date: June 15, 2022
Public Version Number: 1
DI Record Publish Date: June 07, 2022