Duns Number:176528040
Device Description: 6115 -3.000 EACH 2" Sterile Gauze Roll6117 -3.000 EACH 3" Sterile Gauze Roll6400 -3.000 EA 6115 -3.000 EACH 2" Sterile Gauze Roll6117 -3.000 EACH 3" Sterile Gauze Roll6400 -3.000 EACH GG Triangular Bandage +6213 -4.000 EACH 5x9 Combine Dressing ABD3302 -4.000 EACH GG Cold Pack Medium/Boxed +6254 -2.000 EACH Waterproof Tape 1"x5 yds6253 -2.000 EACH Waterproof Tape 1/2" x 5yds8060 -1.000 EACH CPR Microshield3015 -2.000 EACH GG Alcohol Swabs (50)8053 -1.000 EACH Disposable Airway Assorted Siz6397 -1.000 EACH GG Butterfly Bndg (10)6603 -1.000 EACH Cotton Tip Appl 3" 100/Vial+4105 -1.000 EACH GG 4oz Eye Wash4106 -1.000 EACH GG 8oz Eye Wash6102 -1.000 EACH 2" RIP-N-WRAP6103 -1.000 EACH 3" RIP-N-WRAP3101 -1.000 EACH GG Tri-Antibiotic Ointment (25)6300 -1.000 EACH GG 7/8x3 Fabric Strip Bandage (50)6314 -1.000 EACH GG 1x3 Plastic Strip Bandage (60)6206 -1.000 EACH GG 3x3 Gauze Pads (25)6202 -1.000 EACH GG 2x2 Gauze Pads (25)8215 -1.000 EACH Labtron Stethoscope8213 -1.000 EACH Blood Pressure Unit Adult w/ca7920 -2.000 EACH Glove Wipes8202 -1.000 EACH Paramedic Scissors8200 -1.000 EACH 5 1/2" Band Scissors1193 -1.000 EACH Trauma Kit Hard Pack (Empty)8524 -2.000 EACH Space Blanket +
Catalog Number
1196
Brand Name
Green Guard Deluxe Trauma Kit
Version/Model Number
1196
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
7844f9fb-0d2a-4d4a-8466-f832e6dcc2ee
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
50347682011968
Quantity per Package
1
Contains DI Package
00347682011963
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |