Duns Number:103169095
Device Description: Basic Needs Kit, EP4, BP500, WS100, 4412H (10pk) & 879 - 1 Kit
Catalog Number
-
Brand Name
Basic Needs Kit, EP4, BP500, WS100, 4412H (10pk) & 879
Version/Model Number
BNK-T-BAHJ-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
772738cb-3533-4263-a03d-f1ba7068bef1
Public Version Date
May 12, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10843356102403
Quantity per Package
25
Contains DI Package
00843356102406
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 |