Duns Number:134614411
Device Description: Sterile (15.2 x 147cm) telescopically-folded polyethylene cover for use in vascular access Sterile (15.2 x 147cm) telescopically-folded polyethylene cover for use in vascular access procedures
Catalog Number
610-989
Brand Name
iVAS Transducer Cover
Version/Model Number
610-989
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
K970513,K970513
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
492378c6-08c4-4492-a7db-24677d2592d5
Public Version Date
September 06, 2021
Public Version Number
5
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104722
Quantity per Package
24
Contains DI Package
10841436104729
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |