AccessGUDID - DEVICE: American Red Cross (00092265005623)

GUDID

Device Identifier (DI) Information

Brand Name: American Red Cross
Version or Model: RC-562
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RC-562
Company Name: Acme United Corporation

Primary DI Number: 00092265005623
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: American Red Cross Emergency Preparedness Plus First Aid Kit - Contains: Call 9-1-1" banner; 2" Conforming gauze roll; 2" x 2" Gauze dressing pads (6); 2" x 2" Moleskin squares (2); 3/4" x 3" Adhesive fabric bandages (10); 3/4" x 3"); Adhesive plastic bandages (20); 3/8" x 1-1/2" Junior adhesive bandages(10); 4" x 4" Gauze dressing pads (2); 5" x 9" Trauma pad; Alcohol cleansing pads (6); American Red Cross first aid guide; Butterfly wound closures (3); BZK antiseptic towelettes (6); Cotton-tipped applicators (10); Emergency blanket; Emergency drinking water pouch; Emergency Preparedness reference card; Exam quality vinyl gloves (2); Finger splint; Fingertip fabric bandages (2); First aid tape roll; Germicidal wipe; Hand sanitizer packs (2); Hand warmers (2); Knuckle fabric bandages (2); Light stick; Patch bandages, 1-1/2" x 1-1/2"(2); Procedural face masks (2); Rain Poncho; Sterile eye pad; Triple antibiotic ointment packs (3); Whistle.

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: 37c32657-b1c0-461c-bbde-2bb3eca8db49
Public Version Date: April 15, 2021
Public Version Number: 2
DI Record Publish Date: September 16, 2020