Duns Number:878070325
Device Description: Shelter in Place Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x60 Disposab Shelter in Place Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x60 Disposable White Rayon Sheet, 13x17 Disposable Pillow, Terry Washcloth (2), 22x44 White Terry Bath Towel, 2 oz Hand Sanitizer, .85 oz Toothpaste, .64 oz Deodorant Soap, Plastic Soap Dish, and Toothbrush.
Catalog Number
10-7010
Brand Name
Bosma Enterprises
Version/Model Number
10-7010
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NXZ
Product Code Name
Dental Hygiene Kit
Public Device Record Key
6fbebd88-bd04-4768-86e1-d5b157ff367e
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020861
Quantity per Package
8
Contains DI Package
00818634020864
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 | 72 |