Duns Number:071595540
Device Description: LEAD WIRE BULK PACK
Catalog Number
1514848000
Brand Name
NA
Version/Model Number
1514848000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 13, 2020
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
-
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
K912415,K912415,K912415
Product Code
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
82a6379a-2614-41f8-be76-5340256b0f5b
Public Version Date
October 14, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405064210
Quantity per Package
100
Contains DI Package
10653405064213
Package Discontinue Date
December 31, 2016
Package Status
Not in Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |