Duns Number:597723837
Device Description: Transfer Cap Set is a single-use device intended to aid sterile transfer of fluids between Transfer Cap Set is a single-use device intended to aid sterile transfer of fluids between blood culture bottles and vacuum tubes. The device is for use by trained laboratory staff, in a laboratory.
Catalog Number
A100730
Brand Name
Transfer Cap Set
Version/Model Number
A100730
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
LIB
Product Code Name
Device, General Purpose, Microbiology, Diagnostic
Public Device Record Key
4c56ed2a-f117-4b0d-bba2-54a6c48f1673
Public Version Date
May 11, 2022
Public Version Number
4
DI Record Publish Date
February 29, 2020
Package DI Number
19555240401394
Quantity per Package
6
Contains DI Package
19555240401387
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |