Duns Number:134614411
Device Description: Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hy Sterile (14 x 91.5cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophilic ultrasound pad
Catalog Number
H2O-004. H2O-004-5, H2O-004-MC
Brand Name
envision Transducer Cover
Version/Model Number
H2O-004. H2O-004-5
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"
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
K190802,K190802,K190802
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
0765b38e-fb7b-470f-93ad-947b4702826c
Public Version Date
September 06, 2021
Public Version Number
3
DI Record Publish Date
June 19, 2019
Package DI Number
00841436114912
Quantity per Package
5
Contains DI Package
10841436114902
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 |