Duns Number:064437304
Device Description: Mountain Series Fundamentals 8 - Bandage, Adhesive, Fabric, 1" x 3"5 - Bandage, Adhesive, Mountain Series Fundamentals 8 - Bandage, Adhesive, Fabric, 1" x 3"5 - Bandage, Adhesive, Fabric, Knuckle2 - Bandage, Conforming Gauze, 3"1 - Bandage, Stockinette Tubular, 1" x 4"2 - Dressing, Gauze, Sterile, 2" x 2", Pkg./23 - Dressing, Gauze, Sterile, 4" x 4", Pkg./23 - Dressing, Non-Adherent, Sterile, 3" x 4"2 - Gloves, Nitrile (Pair), Hand Wipe1 - Instructions, Easy Care Bleeding1 - Trauma Pad, 5" x 9"1 - Trauma Pad, 8" x 10"1 - Aloe Vera Gel with Lidocaine, 1 oz2 - GlacierGel (Small Rectangular)1 - Moleskin, Pre-Cut & Shaped (14 pieces)1 - CPR Face Shield1 - Duct Tape, 2" x 5 Yards1 - Bandage, Elastic with Hook-&-loop fastener, 3"1 - Bandage, Triangular1 - Instructions, Easy Care Fracture & Sprain1 - C-Splint, 4" x 36"1 - EMT Shears, 4"1 - Pencil3 - Safety Pins1 - Splinter Picker/Tick Remover Forceps1 - Thermometer, Digital1 - Comp. Guide to Wilderness & Travel Medicine1 - Patient Assessment Form4 - Acetaminophen (500 mg), Pkg./24 - Antihistamine (Diphenhydramine 25 mg)1 - Aspirin (325 mg), Pkg./24 - Ibuprofen (200 mg), Pkg./21 - Instructions, Easy Care Medications2 - Plastic Vial, Flip-top, Large6 - Antiseptic Wipe2 - Cotton Tip Applicator, Pkg./21 - Instructions, Easy Care Wound1 - Povidone Iodine, 3/4 oz1 - Syringe, Irrigation, 20 cc, 18 Gauge Tip1 - Tape, 1" x 10 Yards2 - Skin Tac Adhesive, Wipes3 - Triple Antibiotic Ointment, Single Use1 - Wound Closure Strips, 1/4" x 4", Pkg./10
Catalog Number
0100-0120
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
b7088af0-d596-4d2c-a1b3-951d75f391d4
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
-