Duns Number:007924756
Device Description: First Aid Kit, 45 items: 10 - Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 10 - Sheer First Aid Kit, 45 items: 10 - Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 10 - Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 10 - Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 10 - Alcohol Prep Pad 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 2 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 2 - Triple Antibiotic Ointments 1/32 OZ (0.9 g); 1 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 1 - Carrying Case
Catalog Number
-
Brand Name
H-E-B
Version/Model Number
041220216772
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
cccc398d-7960-4e07-911f-b7c8fee50f1c
Public Version Date
May 07, 2020
Public Version Number
1
DI Record Publish Date
April 29, 2020
Package DI Number
20041220216776
Quantity per Package
24
Contains DI Package
00041220216772
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |