Duns Number:064437304
Device Description: Mountain Series Daytripper Bandage Materials5 - Bandage, Adhesive, Fabric, 1" x 3"3 - Band Mountain Series Daytripper Bandage Materials5 - Bandage, Adhesive, Fabric, 1" x 3"3 - Bandage, Adhesive, Fabric, Knuckle4 - Bandage, Butterfly Closure2 - Dressing, Gauze, Sterile, 2" x 2", Pkg./22 - Dressing, Gauze, Sterile, 4" x 4", Pkg./22 - Dressing, Non-Adherent, Sterile, 2" x 3"Bleeding1 - Gloves, Nitrile (Pair), Hand Wipe1 - Trauma Pad, 5" x 9"Blister / Burn1 - Moleskin, Pre-Cut & Shaped (14 pieces)Fracture / Sprain1 - Bandage, Elastic with Velcro, 2"Instrument2 - Safety Pins1 - Splinter Picker/Tick Remover ForcepsMedical Information1 - Comp. Guide to Wilderness & Travel MedicineMedication2 - After Bite Wipe2 - Antihistamine (Diphenhydramine 25 mg)2 - Aspirin (325 mg), Pkg./22 - Diamode (Loperamide HCI 2 mg), Pkg./13 - Ibuprofen (200 mg), Pkg./2Wound Care4 - Antiseptic Wipe2 - Alcohol Swab1 - Cotton Tip Applicator, Pkg./21 - Syringe, Irrigation, 10 cc, 18 Gauge Tip1 - Tape, 1" x 10 Yards1 - Skin Tac Adhesive Wipes3 - Triple Antibiotic Ointment, Single Use
Catalog Number
0100-0116
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
75dfe8dc-d8bb-4ec2-a904-b20eef039bc0
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
-