Duns Number:167450993
Device Description: Hi-Vac Tubing
Catalog Number
B5558
Brand Name
Hi-Vac Tubing
Version/Model Number
B5558
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
KGZ
Product Code Name
ACCESSORIES, CATHETER
Public Device Record Key
c40992d2-e83c-438c-9486-42f4758e67e0
Public Version Date
June 08, 2021
Public Version Number
5
DI Record Publish Date
September 14, 2016
Package DI Number
10081317023446
Quantity per Package
10
Contains DI Package
00081317023449
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10 Pouches/Box
| 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. | 128 |
| 3 | A medical device with high risk that requires premarket approval | 545 |
| U | Unclassified | 514 |