Duns Number:025460908
Device Description: TBG PRESS MON 6IN M/F L/L
Catalog Number
DYNJPMTBG6MF
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJPMTBG6MF
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
DQO
Product Code Name
Catheter, intravascular, diagnostic
Public Device Record Key
5dc8f9f3-61e5-4c27-a226-f39cc55d62ff
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2022
Package DI Number
40889942478133
Quantity per Package
25
Contains DI Package
10889942478132
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |