Duns Number:176528040
Device Description: 8213 -1.000 EACH Blood Pressure Unit Adult w/ca8215 -1.000 EACH Labtron Stethoscope3015 -1 8213 -1.000 EACH Blood Pressure Unit Adult w/ca8215 -1.000 EACH Labtron Stethoscope3015 -1.000 EACH GG Alcohol Swabs (50)6102 -1.000 EACH 2" RIP-N-WRAP6520 - 2.000 EACH Emergency Large Wound Dressing3302 -4.000 EACH GG Cold Pack Medium/Boxed +6400 -2.000 EACH GG Triangular Bandage +8200 -1.000 EACH 5 1/2" Band Scissors8202 -1.000 EACH Paramedic Scissors6253- 2.000 EACH Waterproof Tape 1/2" x 5yds6254 -2.000 EACH Waterproof Tape 1"x5 yds8060 -1.000 EACH CPR Microshield6206 -1.000 EACH GG 3x3 Gauze Pads (25)4106 -2.000 EACH GG 8oz Eye Wash6314 1.000 EACH GG 1x3 Plastic Strip Bandage (60)6115- 2.000 EACH 2" Sterile Gauze Roll8053 -1.000 EACH Disposable Airway Assorted Sizes1193 -1.000 EACH Trauma Kit Hard Pack (Empty)8524 -1.000 EACH Space Blanket +7920 -2.000 EACH Glove Wipes6117 -2.000 EACH 3" Sterile Gauze RollSS110 - 1.000 EACH MCR Stratos Black/Clear8212I- 2.000 EACH Penlight Disposable - Ind.
Catalog Number
1195
Brand Name
Green Guard Trauma Kit
Version/Model Number
1195
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
62054e6e-43ce-4f2b-923e-7094f9593000
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
50347682119558
Quantity per Package
1
Contains DI Package
00347682119553
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 |