Duns Number:079861573
Device Description: 903 Filter Paper Lot#-variable
Catalog Number
-
Brand Name
903™
Version/Model Number
Variable
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
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
305d29bb-4f8f-4bb3-a094-743615593777
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 28, 2022
Package DI Number
10850039198011
Quantity per Package
7200
Contains DI Package
00850039198014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |