Duns Number:079375431
Device Description: Assisted Care 24-Hour Oral Care Kit with Suction Tools (Mexico)
Catalog Number
970600
Brand Name
Halyard
Version/Model Number
47448
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
5d9309e9-7ac3-452b-a0e5-c868af84e8cb
Public Version Date
November 16, 2018
Public Version Number
2
DI Record Publish Date
August 25, 2018
Package DI Number
30680651474484
Quantity per Package
20
Contains DI Package
20680651474487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |