Duns Number:878070325
Device Description: Shelter in Place and Hygiene Combo Kit; Each Kit Includes 40x80 Disposable Grey Poly Blank Shelter in Place and Hygiene Combo Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 13x17 Disposable Pillow, Terry Washcloth (2), 22x44 White Terry Bath Towel, Comb, 4 oz Shampoo/Body Wash, 4 oz Hand and Body Lotion, 2 oz Conditioner, 2 oz Mouthwash, 2 oz Roll-On Antiperspirant Deodorant, Singe Edge Razor, .85 oz Shaving Cream, .85 oz Toothpaste and Toothbrush.
Catalog Number
10-7100
Brand Name
Bosma Enterprises
Version/Model Number
10-7100
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
c0256686-9607-4602-b8d9-6b0a7a24ac9a
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020892
Quantity per Package
6
Contains DI Package
00818634020895
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 |