Duns Number:025460908
Device Description: BLD COLL SET, 25GX0.75", PREATTACH HLDR
Catalog Number
DYNDTNHBC25G
Brand Name
Medline
Version/Model Number
DYNDTNHBC25G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
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
K151991,K151991,K151991
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
1bc08b2e-f802-4c27-a6ae-1690c6cc216f
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
November 25, 2020
Package DI Number
20193489013136
Quantity per Package
50
Contains DI Package
10193489013139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |