AccessGUDID - DEVICE: First Aid Only (00738743054997)

GUDID

Device Identifier (DI) Information

Brand Name: First Aid Only
Version or Model: 5499
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5499
Company Name: Acme United Corporation

Primary DI Number: 00738743054997
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: 36 Unit First Aid Kit With BBP And CPR, Metal Case - Contains: Adhesive Fabric Bandages, 2" x 4", 6ct; Adhesive Plastic Bandages, 1" x 3", 16ct; Antiseptic Wipes, 10ct; BBP Personal Protection Pack (10 pieces); Body Fluid Spill Clean-Up Pack (21 pieces); Cold Pack, 4" x 5"; CPR Face Shield, 2 Nitrile Exam Gloves and 2 antiseptic wipes; Eyewash, 1oz with 2 Eye Pads and Strips; Fingertip Fabric Bandages, 10ct; First Aid Guide; First Aid Tape, 1/2" x 5yd, 2ct, First Aid/Burn Cream Packets, 12ct; Hema-Seal 8x10 Trauma Pad in 4" x 4yd gauze, 2 Nitrile Exam Gloves; Hydrocortisone Anti-Itch Cream Packets, 12ct; Knuckle Fabric Bandages, (8ct); Nitrile Exam Gloves, 4ct; Sterile Gauze Pads, 3" x 3", 4ct; Sting Relief Wipes, 10ct; Tecnu Oak & Ivy Post-Contact Cleanser Packets, 4ct; Triangular Bandage, 40" x 40" x 56"; Triple Antibiotic Ointment Packets, 12ct.

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: ee1b25c9-bc3f-4be3-a6a3-9ed93238e213
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: September 17, 2020