Duns Number:023904428
Device Description: PAPER, THERMAL ADHSV F/121-120
Catalog Number
-
Brand Name
McKesson
Version/Model Number
121-PP
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"
Yes
For Single-Use
-
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
JIL
Product Code Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Public Device Record Key
6d116e44-25ef-48e9-80c8-e253e2c91f32
Public Version Date
October 31, 2022
Public Version Number
3
DI Record Publish Date
March 13, 2020
Package DI Number
40612479183641
Quantity per Package
50
Contains DI Package
20612479183678
Package Discontinue Date
-
Package Status
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 | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |