Duns Number:064437304
Device Description: Mountain Series HikerCuts & Scrapes1 – Splinter Picker/Tick Remover Forceps5 – Easy Access Mountain Series HikerCuts & Scrapes1 – Splinter Picker/Tick Remover Forceps5 – Easy Access Bandages®, 1" x 3" Fabric5 – Easy Access Bandages®, Knuckle Fabric3 – Butterfly Closure Fabric Adhesive Bandage3 – Antiseptic Wipe1 – Triple Antibiotic Ointment2 – Alcohol Swab1 – Safety Pin1 – Register Your Kit CardMedication3 – After Bite® Sting & Bite Relief Wipe4 – Aspirin (325 mg.), 2 Pkg./22 – Antihistamine (Diphenhydramine 25 mg.), 2 Pkg./14 – Ibuprofen (200 mg.), 2 Pkg./24 – Acetaminophen (500 mg.), 2 Pkg./2Stop Bleeding Fast1 – Trauma Pad, 5" x 9"2 – Nitrile GloveWound Care / Blister / Burn1 – Wilderness First Aid Manual1 – EMT Shears, 4"4 – Sterile Gauze Dressing, 4" x 4"2 – Sterile Gauze Dressing, 2" x 2"1 – Sterile Non-Adherent Dressing, 2" x 3"1 – Elastic Bandage with Hook & Loop Closure, 2"1 – Conforming Gauze Bandage, 2"1 – Tape, 1" x 2.5 yd.14 – Moleskin, Pre-Cut & Shaped Pieces
Catalog Number
0100-1001
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
ed2866eb-fb13-412f-9742-8fbc2122e2a8
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
-