Duns Number:064437304
Device Description: Mountain Series GuideCuts & Scrapes10 – Easy Access Bandages®, 1" x 3" Fabric5 – Easy Acce Mountain Series GuideCuts & Scrapes10 – Easy Access Bandages®, 1" x 3" Fabric5 – Easy Access Bandages®, Knuckle Fabric10 – Antiseptic Wipe3 – Triple Antibiotic Ointment4 – Alcohol Swab2 – Tincture of BenzoinFracture / Sprain1 – C-Splint™, Aluminum & Foam Padded, 4" x 36"1 – Triangular Bandage1 – Elastic Bandage with Hook & Loop Closure, 3"Instruction / Instrument1 – Wilderness & Travel Medicine: A Comprehensive Guide1 – Digital Thermometer, 90°F – 105°F1 – CPR Face Shield1 – EMT Shears, 4"1 – Duct Tape, 2" x 2.5 yd.1 – Splinter Picker/Tick Remover Forceps3 – Safety Pin2 – Plastic Vial (Large Flip-top)1 – Patient Assessment Form1 – Pencil1 – Register Your Kit CardMedication3 – After Bite® Sting & Bite Relief Wipe4 – Diamode (Loperamide HCI 2 mg.), 4 Pkg./18 – Aspirin (325 mg.), 4 Pkg./24 – Antihistamine (Diphenhydramine 25 mg.), 4 Pkg./116 – Ibuprofen (200 mg.), 8 Pkg./28 – Acetaminophen (500 mg.), 4 Pkg./2Stop Bleeding Fast1 – QuikClot® Gauze, 3” x 24”1 – Trauma Pad, 8" x 10"1 – Trauma Pad, 5” x 9”4 – Nitrile GloveWound Care / Blister / Burn1 – Wound Irrigation Tool, 20cc. with 18 Gauge Tip10 – Wound Closure Strip, 1/4" x 4"6 – Sterile Gauze Dressing, 4" x 4"6 – Sterile Gauze Dressing, 2" x 2"3 – Sterile Non-Adherent Dressing, 3" x 4"2 – Conforming Gauze Bandage, 3"1 – Tape, 1" x 10 yd.2 – GlacierGel™ Blister & Burn Dressing, (Small Rectangular)28 – Moleskin, Pre-Cut & Shaped Pieces4 – Cotton Tip Applicator
Catalog Number
0100-1007
Brand Name
Adventure Medical Kits
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
34d43bb9-57a8-4542-9382-390889979249
Public Version Date
September 17, 2020
Public Version Number
2
DI Record Publish Date
December 27, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-