Duns Number:176528040
Device Description: 6216 -1.000 EACH 8x10 Combine Dressing -Sterile6213- 2.000 EACH 5x9 Combine Dressing ABD62 6216 -1.000 EACH 8x10 Combine Dressing -Sterile6213- 2.000 EACH 5x9 Combine Dressing ABD6215 -1.000 EACH GG Non-Adherent Pads (15) +6211- 1.000 EACH 4 X 4 Gauze Pads (10)6400B- 1.000 EACH Triangular Bandage Bulk6397 -1.000 EACH GG Butterfly Bandage (10)3302B -1.000 EACH GG Cold Pack Medium/Bulk +4154B- 2.000 EACH Large Eye Pads6249- 1.000 EACH Elastic Tape 1"x 5yds6254- 1.000 EACH Waterproof Tape 1"x5 yds80201- 2.000 EACH CPR Mask8205- 1.000 EACH Kit Scissors8203 -2.000 EACH Plastic Single-use Tweezer646B -0.004 M HW Ltx Free Wvn Patch 644B -0.004 M HW Ltx Fre Wvn XL Fingertip6103 -1.000 EACH 3" RIP-N-WRAP6113 -2.000 EACH 3" Stretch Roller Gauze7920 2.000 EACH Glove Wipes9016-B- 1.000 EACH First Aid Booklets Ind. for +9800 1.000 EACH MCR Yukon Clear Lens3004- 1.000 EACH GG Hydrogen Peroxide 2oz pump3160 -2.000 EACH WJ Burn Dressing 4x422312 -1.000 EACH Triple Antibiotic Ointment 10c6508- 1.000 EACH GG Fabric Strip Bandage Unit (10)3025B- 6.000 EACH Antiseptic Towlettes 4110 -1.000 EACH GG 1oz Eye Wash3021I -3.000 EACH Iodine Prep Pads Individual1192 -1.000 EACH Trauma Kit Empty Fanny Pack
Catalog Number
1194
Brand Name
Green Guard Fanny Pack Emergancy Kit
Version/Model Number
1194
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
-
Product Code Name
-
Public Device Record Key
60f631ec-fb71-4763-93b0-a7ea982a54ab
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
50347682011944
Quantity per Package
1
Contains DI Package
00347682011949
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 |