Duns Number:103169095
Device Description: Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Water Bowl, Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Water Bowl, 10X 4X4 GAUZE AND 2 OZ LUBE, 1 Kit
Catalog Number
-
Brand Name
Basic Needs Kit contains - First Step Kit (500 ml EP-6 Kit), Blue Bowl, WS100 Wa
Version/Model Number
BNK-T-BBHJ-PAD-M
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
MNL
Product Code Name
Accessories, Cleaning Brushes, For Endoscope
Public Device Record Key
0d6469e4-d18d-47dd-a8f1-9edde733d67d
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
Package DI Number
10843356101789
Quantity per Package
25
Contains DI Package
00843356101782
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 146 |