Duns Number:106712748
Catalog Number
-
Brand Name
BCI
Version/Model Number
1303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K920082,K920082
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
be8606be-a1b7-464d-af5f-a97c0ed8d2d0
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
October 13, 2016
Package DI Number
35019517042515
Quantity per Package
10
Contains DI Package
15019517042511
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |