AccessGUDID - DEVICE: SAS Safety Corp (00781311700857)

GUDID

Device Identifier (DI) Information

Brand Name: SAS Safety Corp
Version or Model: 6025-025 / 16-SAS-1601568A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6025-025
Company Name: Bunzl USA Holdings LLC

Primary DI Number: 00781311700857
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 799540588 *Terms of Use

Device Description: First Aid Kit - 25 Person Kit - 200 Pieces - Contents 200 pieces: (1) SILVEX Wound Gel 0.18 oz (15) Alcohol Prep Pads (15) Antiseptics Wipes (10) Hand Sanitizers (1) Eye Wash 1.01 fl oz (10) Antibiotic Ointments 0.03 oz (10) Burn Creams 0.03 oz (1) Burn Dressing 4 in X 4 in (1) Instant Cold Compress 5 in x 6 in (1) Emergency Blanket 84 in X 52 in (30) Sheer Bandages 3/4 in X 3 in (20) Sheer Bandages 3/8 in X 1 1/2 in (20) Sheer Bandages 1 in X 3 in (10) Sterile Gauze Pads 4 in X 4 in / 4ply (10) Sterile Gauze Pads 2 in X 2 in / 4ply (10) Butterfly Closures (2) Eye Pads 3.15 in X 2.36 in (2) Sterile Trauma Pad 5 in X 9 in (1) Triangular Bandage w/ Safety Pins (1) Gauze Roll 2 in X 147.60 in (10) Cotton Tip Applicators (5) Safety Pins (5) Wood Splints (4) Examination Gloves - 2 pairs (1) Paper Tape 1/2 in X 180 in (5yrd) (1) Scissors (1) Tweezers (1) CPR Mask (1) First Aid Guide

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):	Yes
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
LRR	First Aid Kit With Drug

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: 93a059a1-0bf7-4cb4-92de-490244337cab
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: February 01, 2025