AccessGUDID - DEVICE: Cramer Sports Medicine Coach's Team First Aid Kit (00311960743310)

GUDID

Device Identifier (DI) Information

Brand Name: Cramer Sports Medicine Coach's Team First Aid Kit
Version or Model: 761208
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CRAMER PRODUCTS, INC.

Primary DI Number: 00311960743310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007138183 *Terms of Use

Device Description: Coach's Team First Aid Kit: Sterile Eye Pad 1 Sterile Eye Wash 10ml 1 Butterfly Wound Closure 1 First Aid Tape Toll 1 Bloodstopper Dressing 1 CPR Breathing Barrier 1 Medical Grade Gloves 2 Alcohol Cleansing Pad 1 Chewable Aspirin Tablets 2 Triangular Bandage 1 Instant cold Pack 1 Emergency First Air Guide 1 Plastic Tweezers 1 Assorted Safety Pins 6 Adhesive Plastic Bandages” 25 Junior Plastic Bandages 3/8” x 1-1/2” 25 Adhesive Plastic Bandage 1” x 3” 1 Adhesive Spot Bandage 7/8” x 7/8” 1 Elbow/Knee Adhesive Bandage 1 Burn Cream 1 Antiseptic Towelette 2 Sterile Gauze Pad 2” x 2” 1 Cotton Tipped Applicators 20 Pressure Bandage 2” x 2” 1 Pressure Bandage 3” x 3” 1

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
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?
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use 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: 81b9c9f9-7df7-4861-b9c0-f0640e72a638
Public Version Date: May 01, 2019
Public Version Number: 1
DI Record Publish Date: April 23, 2019