AccessGUDID - DEVICE: EMPACT 6+ Patient Trauma Kit with Batons-OTC (B283E6HCXOC0)

GUDID

Device Identifier (DI) Information

Brand Name: EMPACT 6+ Patient Trauma Kit with Batons-OTC
Version or Model: B283E6HCXOC0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pro1tek

Primary DI Number: B283E6HCXOC0
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 Hart Case Kit with Batons and Extra Hemostatic Dressing. Tactical & Medical Trauma Kit. Tactical side Has Batons, TAC-Wedge, TAC-Keys and other Tactical components that can be used in an active shooter RUN, HIDE, FIGHT situation. Medical side has OTC Bleeding Control Kits featuring extra Hemostatic Dressing and other Trauma First-Aid equipment .

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?
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: 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: 1ac94a0f-1882-4970-a199-6672459fb8a8
Public Version Date: March 31, 2022
Public Version Number: 1
DI Record Publish Date: March 23, 2022