Duns Number:025460908
Device Description: BLD COLL SET, 21GX0.75", 7IN TUBING
Catalog Number
DYNDTNBC21G7
Brand Name
Medline
Version/Model Number
DYNDTNBC21G7
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
b592e643-5cf1-4ef6-ab67-9fc747869ec7
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 16, 2020
Package DI Number
30193489010408
Quantity per Package
200
Contains DI Package
20193489010401
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 |