Duns Number:176528040
Device Description: 1126 -1.000 EACH GG 2 Shelf Cabinet Emp w/Pkt62730 -1.000 EACH Woven Knuckle 8s6507 -1.000 1126 -1.000 EACH GG 2 Shelf Cabinet Emp w/Pkt62730 -1.000 EACH Woven Knuckle 8s6507 -1.000 EACH GG Hydrocortisone Unit (10)62612 -1.000 EACH Fingertip Woven M/L 10s6314 -1.000 EACH GG 1x3 Plastic Strip Bndg (60)6253 -1.000 EACH Waterproof Tape 1/2" x 5yds6206 -1.000 EACH GG 3x3 Gauze Pads (25)4105 -1.000 EACH GG 4oz Eye Wash2209 - 1.000 EACH Pain & Ache relief (100)6400 -2.000 EACH GG Triangular Bandage +6213 -4.000 EACH 5x9 Combine Dressing ABD3004 -1.000 EACH GG Hydrogen Peroxide 2oz pump3002 -1.000 EACH GG Derma Cool (2 oz.)1125PI- 1.000 EACH Pocket Items 2 shelf Kit3302 -2.000 EACH GG Cold Pack Medium/Boxed +66002 -1.000 EACH Latex Free Tourniquet76001 -1.000 EACH Multi-Purpose Splint Folded6112 -2.000 EACH 2" Stretch Roller Gauze NS6114 -1.000 EACH 4" Stretch Roller Gauze3106 -1.000 EACH GG Derma-Caine Burn Cream (25)3101 -1.000 EACH GG Tri-Antibiotic Ointment (25)3025 -2.000 U GG Antiseptic Towelettes (25)80201 -1.000 EACH CPR Mask3160 -2.000 EACH WJ Burn Dressing 4x46252- 1.000 EACH Tape 1/2" X 2 1/2 YANSI-B -1.000 EACH ANSI STICKER B
Catalog Number
1125
Brand Name
Green Guard Super Utility Kit
Version/Model Number
1125
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
7b5df33a-bed2-4a8b-aad3-5a659925064c
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
50347682011258
Quantity per Package
1
Contains DI Package
00347682011253
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 |