AccessGUDID - DEVICE: American Red Cross (00092265910538)

GUDID

Device Identifier (DI) Information

Brand Name: American Red Cross
Version or Model: 91053
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91053
Company Name: Acme United Corporation

Primary DI Number: 00092265910538
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: 4-Person, 3-Day Emergency Preparedness Kit, with first aid containing: Heavy-Duty Durable Backpack; 4 - LED Flashlights; Crank-powered Flashlight/Radio/Cell-phone charger with Weather band, solar panel, earphone jack, SOS Alarm and lithium-ion battery; Multi-Tool; 4 - Emergency Food bars (6 pack); 16 - Emergency Water pouches 4 oz.; 4 - 2.5g al Portable Water Bags; 4 - Emergency Rain Ponchos; 4 - Emergency Whistles; 4 - Aluminized Rescue Blankets 52" x 84"; 8 - Hand Warmers; 4 - Dust-Protection Face Masks; Duct Tape; Hand Sanitizer Bottle 50 ml ; 4 - Mesh Bags for Comfort Supplies; 4 - 4" Ivory Toothbrush 30 Tuft; 4 - Fluoride Toothpaste .6oz Tubes; 4 ; Disposable razors; 4 - Travel Shave Gels; 4 - Travel Tissues (15 Pack); 4 - Wash Cloths; 4 - Hair Combs; 4 - Travel Bars of Soap; 4 - Travel Shampoo/Body Washes; 4 - Travel Roll-on Deodorants; 4 - Hand and Body Lotions; First Aid Supplies Zip Pouch; First Aid Guide Book; Nitrile Exam Gloves (2 per Bag); 6 - BZK Antiseptic Wipes; 3 - Triple Antibiotic Ointment Packets; 5” x 9” Trauma Pad; 0.5” x 5 yard First Aid Tape; 2" Conforming Gauze Roll; 2" x 4" Plastic Bandage; 2" x 2" Sterile Gauze Pads; 2 - 0.75" x 3" Plastic Bandages (5 Pack); 1" x 3" Plastic Bandages (5-Pack); 5 - Junior Adhesive Bandages; 1.5 x 1.5 Patch Bandage; 10 - 7/8" Spot Round Bandages; 3 - Butterfly Wound Closures; Aspirin Tablets (2 pack); Extra-strength Non-Aspirin (2 pack); Ibuprofen Tablets (2 pack)

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: 7a76f9ad-4ffa-40e1-8615-b2928e14c624
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: October 01, 2020