Duns Number:064437304
Device Description: Mountain Series Comprehensive Bandage Materials10 - Bandage, Adhesive, Fabric, 1" x 3"10 - Mountain Series Comprehensive Bandage Materials10 - Bandage, Adhesive, Fabric, 1" x 3"10 - Bandage, Adhesive, Fabric, Knuckle2 - Bandage, Conforming Gauze, 3"2 - Bandage, Stockinette Tubular, 1" x 4"4 - Dressing, Gauze, Sterile, 2" x 2", Pkg./24 - Dressing, Gauze, Sterile, 4" x 4", Pkg./24 - Dressing, Non-Adherent, Sterile, 3" x 4"2 - Eye Pad, SterileBleeding3 - Gloves, Nitrile (Pair), Hand Wipe1 - Instructions, Easy Care Bleeding1 - Trauma Pad, 5" x 9"1 - Trauma Pad, 8" x 10"Blister / Burn1 - Aloe Vera Gel with Lidocaine, 1 oz2 - GlacierGel (Small Rectangular)1 - Molefoam, 5" x 6"2 - Moleskin, Pre-Cut & Shaped (14 pieces)CPR1 - CPR Face Shield1 - Instructions, Easy Care CPRDental1 - Dentemp, Filling Mixture with Pain ReliefDuct Tape1 - Duct Tape, 2" x 5 YardsFracture / Sprain1 - Bandage, Elastic with Velcro, 3"2 - Bandage, Triangular1 - Instructions, Easy Care Fracture & Sprain1 - C-Splint™, 4" x 36"Instrument1 - EMT Shears, 4"1 - Pencil3 - Safety Pins1 - Splinter Picker/Tick Remover Forceps1 - Thermometer, DigitalMedical Information1 - Comp. Guide to Wilderness & Travel Medicine3 - Patient Assessment FormMedication5 - Acetaminophen (500 mg), Pkg./23 - After Bite Wipe1 - Antacid, Pkg./126 - Antihistamine (Diphenhydramine 25 mg)2 - Aspirin (325 mg), Pkg./25 - Cold Medicine, Medicidin-D, Pkg./23 - Cortisone Cream 1%, 1/32 oz (.9 g)6 - Diamode (Loperamide HCI 2 mg), Pkg./11 - Glutose Paste (Glucose 15 g)5 - Ibuprofen (200 mg), Pkg./21 - Instructions, Easy Care Medications2 - Oral Rehydration SaltsOther2 - Dryflex Waterproof Bag, 6" x 9"2 - Plastic Vial, Flip-top, Large2 - Plastic Vial, Flip-top, SmallSurvival Tools1 - Matches, WaterproofSuture / Syringe1 - Scalpel, Sterile, Disposable, #11 BladeWound Care6 - Antiseptic Wipe2 - Cotton Tip Applicator, Pkg./21 - Instructions, Easy Care Wound2 - Povidone Iodine, 3/4 oz1 - Scrub Brush, Sterile1 - Syringe, Irrigation, 20 cc, 18 Gauge Tip1 - Tape, 1" x 10
Catalog Number
0100-0101
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
731661a7-da21-4ccc-8926-3a50b3419735
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
-