Duns Number:013112308
Device Description: SAFETY BLOOD COLLECTION HOLDER WITH PREMOUNTED SAFETY NEEDLE 23G X 3/4", EA.
Catalog Number
SFTBCH23
Brand Name
Rospital Productos Medicos
Version/Model Number
SFTBCH23
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
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
9642fe0b-db32-4145-989d-9c3241d4049b
Public Version Date
February 23, 2022
Public Version Number
4
DI Record Publish Date
June 13, 2020
Package DI Number
10812460027902
Quantity per Package
50
Contains DI Package
00812460027905
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |