Duns Number:001292192
Device Description: KIT URIN TRANSTR 13X75 4.0 C&S GR
Catalog Number
364953
Brand Name
BD Vacutainer® C&S Transfer Straw Kit
Version/Model Number
364953
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024240,K024240,K024240
Product Code
JSM
Product Code Name
CULTURE MEDIA, NON-PROPAGATING TRANSPORT
Public Device Record Key
722264f4-5a46-4c04-9642-6ec7c5d0656a
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
November 16, 2020
Package DI Number
30382903649533
Quantity per Package
50
Contains DI Package
50382903649537
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |