AccessGUDID - DEVICE: Cramer Sports Medicine Fanny Pack First Aid Kit (00311960728300)

GUDID

Device Identifier (DI) Information

Brand Name: Cramer Sports Medicine Fanny Pack First Aid Kit
Version or Model: 111005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CRAMER PRODUCTS, INC.

Primary DI Number: 00311960728300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007138183 *Terms of Use

Device Description: Gauze Pads 3” x 3”, Cramer Instant Cold Pack (large), White Athletic Tape 1-1/2”, Antibiotic Cream Individual, Alcohol Wipes, Sterile, Underwrap Beige 21 yards, 3 Foam Blister – White, Bulk Bandage 3/4” x 3”, Bulk Bandage 2” x 4”, Vytrile Examination Gloves, 3” Elastic Wrap, Black Fanny Pack Empty dimensions: 11.5” x 2.5” x 5.5”

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: a61c344b-4333-4b69-a465-969300d23934
Public Version Date: May 01, 2019
Public Version Number: 1
DI Record Publish Date: April 23, 2019