AccessGUDID - DEVICE: American Red Cross (00092265100137)

GUDID

Device Identifier (DI) Information

Brand Name: American Red Cross
Version or Model: 1001-RC-0103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001-RC-0103
Company Name: Acme United Corporation

Primary DI Number: 00092265100137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: Large Workplace First Aid Kit with Plastic Cabinet - Contains: Adhesive Fabric Bandages, 1" x 3", 25 ct; Adhesive Plastic Bandages, 0.75" x 3", 25 ct; Alcohol Pads, 20 ct: Antibiotic Ointment Packets, 10 ct; Antiseptic Wipes, 20 ct; Butterfly Wound Closures, 10 ct; Castile Soap Towelettes, 10 ct; Conforming Gauze Roll, 2"; Conforming Gauze Roll, 3"; CPR Face Shield and 2 Nitrile Exam Gloves; Elastic Bandage Wrap, 2" x 5 yd; Fingertip Fabric Bandages, 10 ct; First Aid Guide; First Aid Tape, 1/2" x 10 yd; First Aid/Burn Cream Packets, 10 ct; Knuckle Fabric Bandages, 10 ct; Moleskin Blister Prevention, 2" x 2", 10 ct; Nitrile Exam Gloves, 4 ct; Patch Plastic Bandages, 1.5" x 1.5", 10 ct; Scissors; Sterile Gauze Pads, 2" x 2", 10 ct; Sterile Gauze Pads, 3" x 3", 10 ct; Trauma Pad, 5" x 9; Triangular Bandage, 40" x 40" x 56"; Tweezers.

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: ba7c33a0-b25b-47a1-a713-05d91b66c4a6
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: October 06, 2020