Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
8881311248
Brand Name
Monoject
Version/Model Number
8881311248
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GIM
Product Code Name
Tubes, vacuum sample, with anticoagulant
Public Device Record Key
b8917671-ac03-49e9-838a-e0238f88eaad
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
20884521742342
Quantity per Package
10
Contains DI Package
10884521742345
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |