AccessGUDID - DEVICE: First Aid Only (00092265908344)

GUDID

Device Identifier (DI) Information

Brand Name: First Aid Only
Version or Model: 90834
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90834
Company Name: Acme United Corporation

Primary DI Number: 00092265908344
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: 200 Person XXL Metal SmartCompliance Food Service First Aid Cabinet With Medications - Contains: Adhesive Plastic Bandages, 3/8" x 1-1/2", 40 ct; Adhesive Plastic Bandages, 7/8" Round, 30 ct; Alcohol Pads, 20ct; Ammonia Inhalants, 10 ct; Antacid Tablets, 250 ct; Antibiotic Ointment Packets, 40 ct; Antiseptic Spray, 4 oz; Antiseptic Wipes, 40 ct; Aspirin Tablets, 250 ct; Bandage Protectant/Finger Cots, 50 ct; Blue Metal Detectable Fabric Bandages, 1"x 3", 40 ct; Blue Metal Detectable Foam Bandages, 1" x 3", 25 ct; Blue Self Adhering Wrap, 3"; Burn Dressing, 4" x 4" 2 ct; Burn Spray, 4 oz; Castile Soap Towelettes, 10 ct; Cold Pack, 4" x 5" 2 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, 250 ct; Eye Wash, 4 oz bottle; Fabric Bandages, 2" x 4" 6 ct and Butterfly Wound Closures, 10 ct; Fingertip Blue Metal Detectable Fabric Bandages, 20 ct; First Aid Guide; First Aid Tape, 1/2" x 5yd, 2 ct; First Aid/Burn Cream Packets, 40 ct; Hand Sanitizer Packets, 10 ct; Hema-Flex Bandage Compress, 2", 4 ct; Ibuprofen Tablets, 250 ct; Knuckle Blue Metal Detectable Fabric Bandages, 20 ct; Lip Balm, 10 ct; Liquid Skin, 4 ct; Moleskin (Blister Prevention), 2" x 2", 20 ct; Nitrile Exam Gloves, 8 ct; Padded Flexible Splint, 4.25" x 24"; Povidone Iodine Antiseptic Swabs, 10 ct; Scissors; Splinter Out, 10 ct; Sterile Eyepads, 1 oz Eyewash, and 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.

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: 6e2fa289-dce0-4cda-9db0-e4ae408b9b34
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: September 17, 2020