AccessGUDID - DEVICE: EMPACT 6+ Patient Hard Case Kit with Wall Cabinet (B28300)

GUDID

Device Identifier (DI) Information

Brand Name: EMPACT 6+ Patient Hard Case Kit with Wall Cabinet
Version or Model: B28300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pro1tek

Primary DI Number: B28300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827067880 *Terms of Use

Device Description: EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - 6+ Patient Kit with Bat Flashlight contains both Medical and Tactical devices. Tactical helps with the run, hit fit in an active shooter situation. Kit features Hemostatic Dressing and other bleeding control devices and supplies to help in a trauma situation.

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:	No
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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVR	Kit, First Aid, Talking

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
No Device Sizes

Device Record Status

Public Device Record Key: a7948a74-de93-47f8-8b76-b55dfe1ab96d
Public Version Date: June 04, 2021
Public Version Number: 1
DI Record Publish Date: May 27, 2021