Duns Number:788124873
Device Description: Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer diameter.
Catalog Number
-
Brand Name
R Med Collection Set
Version/Model Number
CollSe
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BYY
Product Code Name
Tube, Aspirating, Flexible, Connecting
Public Device Record Key
65f00c8a-52b6-4901-b45d-fae51b8bb0f3
Public Version Date
July 04, 2022
Public Version Number
3
DI Record Publish Date
July 18, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |