AccessGUDID - DEVICE: PRO1TEK IFAK EMT Leg RIG BAG (B283P1FDPD30)

GUDID

Device Identifier (DI) Information

Brand Name: PRO1TEK IFAK EMT Leg RIG BAG
Version or Model: B283P1FDPD30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pro1tek

Primary DI Number: B283P1FDPD30
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827067880 *Terms of Use

Device Description: PRO1TEK IFAK EMT Leg Rig Bag with Hemostatic Dressing, CAT-T, Hyfin Chest Seal, Olaes Bandage, Medical Shears, NPA 28, Olaes Bandage and other medical supplies

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):	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?
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: 5c255922-3a5e-49a2-ae16-6bb3e2465dc2
Public Version Date: June 04, 2021
Public Version Number: 1
DI Record Publish Date: May 27, 2021