AccessGUDID - DEVICE: First Aid Only (00092265325042)

GUDID

Device Identifier (DI) Information

Brand Name: First Aid Only
Version or Model: FA-504
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FA-504
Company Name: Acme United Corporation

Primary DI Number: 00092265325042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: First Responder First Aid Kit, 269 Piece Plastic Case Contains: Adhesive Fabric Bandages, 1" x 3" (30), Adhesive Plastic Bandages, 1" x 3" (10), Adhesive Plastic Bandages, 2" x 4" (10), Adhesive Plastic Bandages, 3/4" x 3" (25), Adhesive Plastic Bandages, 3/8" x 1-1/2" (10), Alcohol Pads (24), Allergy Tablets (4), Antacid Tablets (4), Antiseptic Spray 4oz, Aspirin Tablets (4), Burn Gel Packets (2), Butterfly Wound Closures (4),Antiseptic Wipes (18), Castile Soap Towelettes (3), Cold Pack, 4" x 5", Cold Pack, 6" x 9" (2), Conforming Gauze Roll, 2"(2), Conforming Gauze Roll 3" (2), Cotton Tipped Applicators (6), CPR Face Shield, Digital Thermometer, Elastic Bandage Wrap, 3" x 5yd, Emergency Blanket, 52" x 84", Extra-Strength Non-Aspirin Tablets (8), Eyewash - 4oz, Finger Splint/Tongue Depressor (3), Fingertip Fabric Bandages (2), First Aid Guide, First Aid Tape, 1" x 10yd, Forceps, Hand Sanitizer -4oz, Ibuprofen Tablets (4), Knuckle Fabric Bandages (2), Large Butterfly Wound Closures (4), Lister Bandage Shears, Nitrile Exam Gloves (4), Non-Stick Pad with Adhesive Tabs, 3" x 4" (3), Non-Stick Pads, 2" x 3"(3), Patch Plastic Bandages, 1.5" x .5" (5), Povidone-Iodine Wipes (6), Safety Pins (2), Splinter Remove (10), Sterile Eye Pads (2), Sterile Gauze Pads, 2" x 2" (8), Sterile Gauze Pads, 3" x 3" (4), Sterile Gauze Pads, 4" x 4" (4), Sting Relief Wipes (9),Transparent Dressing, 2.375" x 2.75" (4), Trauma Pad, 5" x 9" (4), Triangular Bandage, 40" x 40" x 56" (2), Triple Antibiotic Ointment Packet, Waterproof Tape, 1" x 5yd, Wire Splint

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: 95b925f6-75f5-4b06-9de1-f137fbad9996
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: September 17, 2020