AccessGUDID - DEVICE: First Aid Only (00092265907323)

GUDID

Device Identifier (DI) Information

Brand Name: First Aid Only
Version or Model: 90732
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90732
Company Name: Acme United Corporation

Primary DI Number: 00092265907323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: 150 Person XL Metal SmartCompliance First Aid Cabinet - Contains: Adhesive Fabric Bandages, 1" x 3", 40 ct; Adhesive Plastic Bandages, 1" x 3", 40 ct; Alcohol Pads, 20 ct; Antacid Tablets, 100 ct; Antibiotic Ointment Packets, 40 ct; Antiseptic Spray, 4 oz; Aspirin Tablets, 100 ct; Burn Dressing, 4" x 4" 2 ct; Burn Spray, 4 oz; Antiseptic Wipes, 40 ct; Cold Pack, 4" x 5" 2 ct; Conforming Gauze Roll, 2", 2 ct; Conforming Gauze Roll, 4"; Cotton Tipped Applicators, 100 ct; CPR Face Shield and 4 Nitrile Exam Gloves; Elastic Bandage Wrap, 3" x 5 yd; Elovate 15 Glucose Slimpak, 2 ct; Extra-Strength Non-Aspirin Tablets, 100 ct; Eye Wash, 4 oz bottle; Fabric Bandages , 2" x 4" , 6 ct, and Butterfly Wound Closures, 1 0ct; Fingertip Fabric Bandages, 20 ct; First Aid Guide; First Aid Tape, 1/2" x 5 yd, 2 ct; First Aid/Burn Cream Packets, 2 x 20 ct; Hand Sanitizer Packets, 10 ct; Ibuprofen Tablets, 100 ct; Knuckle Fabric Bandages, 20ct; Liquid Skin, 4ct; Nitrile Exam Gloves, 8 ct; Padded Flexible Splint, 4.25" x 24"; Patch Plastic Bandages, 1.5" x 1.5", 10 ct; Scissors; Splinter Out, 10 ct; Sterile Eyepads 2 ct, 1oz Eyewash bottle, 0.5" x 5 yd Tape Roll 2 ct; Sterile Gauze Pads, 2" x 2", 10 ct; Sterile Gauze Pads, 3" x 3", 10 ct; Sting Relief Wipes 20 ct, Hydrocortisone Packets, 10 ct; Stretch Tourniquet, 1" x 18";Trauma Pads, 5" x 9", 2 ct; Triangular Bandage, 40" x 40" x 56", 2 ct; Triple Cut Adhesive Tape Roll, 2"; Tweezers; WoundSeal Powder Packs, 2 ct.

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:	Yes
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: ea755927-46cb-4500-8b3a-af8c116562a8
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: September 15, 2020