Duns Number:152793493
Device Description: All-Purpose, First Aid Kit, First aid essentials, 70 items including 1 carrying case: 5 - All-Purpose, First Aid Kit, First aid essentials, 70 items including 1 carrying case: 5 - Fabric Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 10 - Fabric Antibacterial Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 15 - Fabric Antibacterial Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 21 - Sheer Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 4 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 6 - Hand Cleansing Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); 8 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm).
Catalog Number
-
Brand Name
SoundBody
Version/Model Number
481042886102
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"
Yes
For Single-Use
Yes
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
6e99c949-80a1-4839-a50d-c645e3bed095
Public Version Date
September 15, 2020
Public Version Number
1
DI Record Publish Date
September 07, 2020
Package DI Number
20481042886106
Quantity per Package
36
Contains DI Package
00481042886102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |