Duns Number:058614483
Device Description: Pediatric Starter Kit, (1) 186-0200, (5) 186-0206
Catalog Number
-
Brand Name
BIS
Version/Model Number
186-0206
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041670,K143506,K041670,K143506,K041670,K143506
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
fc4f08ea-ba32-4554-9e00-bc6946e35673
Public Version Date
April 28, 2022
Public Version Number
9
DI Record Publish Date
October 13, 2016
Package DI Number
90884521722985
Quantity per Package
9999
Contains DI Package
10884521134546
Package Discontinue Date
April 09, 2021
Package Status
Not 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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |