Duns Number:134139174
Device Description: KIT,VAMP ANESTHESIA 68" 20/CA SAMPLING KIT W/M/F CONN
Catalog Number
48AVMP
Brand Name
VAMP
Version/Model Number
48AVMP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K173586,K896819,K173586,K896819
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
d92643ac-b275-402b-81f6-cf7a3ff81f26
Public Version Date
February 14, 2019
Public Version Number
4
DI Record Publish Date
September 03, 2016
Package DI Number
50690103001346
Quantity per Package
20
Contains DI Package
00690103001341
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |