AccessGUDID - DEVICE: Adventure Medical Kits (00707708012037)

GUDID

Device Identifier (DI) Information

Brand Name: Adventure Medical Kits
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0100-0120
Company Name: Adventure Ready Brands

Primary DI Number: 00707708012037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064437304 *Terms of Use

Device Description: Mountain Series Fundamentals 8 - Bandage, Adhesive, Fabric, 1" x 3" 5 - Bandage, Adhesive, Fabric, Knuckle 2 - Bandage, Conforming Gauze, 3" 1 - Bandage, Stockinette Tubular, 1" x 4" 2 - Dressing, Gauze, Sterile, 2" x 2", Pkg./2 3 - Dressing, Gauze, Sterile, 4" x 4", Pkg./2 3 - Dressing, Non-Adherent, Sterile, 3" x 4" 2 - Gloves, Nitrile (Pair), Hand Wipe 1 - Instructions, Easy Care Bleeding 1 - Trauma Pad, 5" x 9" 1 - Trauma Pad, 8" x 10" 1 - Aloe Vera Gel with Lidocaine, 1 oz 2 - GlacierGel (Small Rectangular) 1 - Moleskin, Pre-Cut & Shaped (14 pieces) 1 - CPR Face Shield 1 - Duct Tape, 2" x 5 Yards 1 - Bandage, Elastic with Hook-&-loop fastener, 3" 1 - Bandage, Triangular 1 - Instructions, Easy Care Fracture & Sprain 1 - C-Splint, 4" x 36" 1 - EMT Shears, 4" 1 - Pencil 3 - Safety Pins 1 - Splinter Picker/Tick Remover Forceps 1 - Thermometer, Digital 1 - Comp. Guide to Wilderness & Travel Medicine 1 - Patient Assessment Form 4 - Acetaminophen (500 mg), Pkg./2 4 - Antihistamine (Diphenhydramine 25 mg) 1 - Aspirin (325 mg), Pkg./2 4 - Ibuprofen (200 mg), Pkg./2 1 - Instructions, Easy Care Medications 2 - Plastic Vial, Flip-top, Large 6 - Antiseptic Wipe 2 - Cotton Tip Applicator, Pkg./2 1 - Instructions, Easy Care Wound 1 - Povidone Iodine, 3/4 oz 1 - Syringe, Irrigation, 20 cc, 18 Gauge Tip 1 - Tape, 1" x 10 Yards 2 - Skin Tac Adhesive, Wipes 3 - Triple Antibiotic Ointment, Single Use 1 - Wound Closure Strips, 1/4" x 4", Pkg./10

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: b7088af0-d596-4d2c-a1b3-951d75f391d4
Public Version Date: September 17, 2020
Public Version Number: 2
DI Record Publish Date: December 27, 2019