Duns Number:007941230
Device Description: Tray Suction Catheter Delee Tip Pediatric Polyvinyl Chloride 8 French 16 Inch 1 Pair Pre-c Tray Suction Catheter Delee Tip Pediatric Polyvinyl Chloride 8 French 16 Inch 1 Pair Pre-cuffed Powder-free Vinyl Gloves 1 Bottle 100 Milliliter Saline Rigid Basin Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
RSC08TSD
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
-
Product Code
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
392ec803-a7e5-48fb-b093-d39ce3130c37
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 20, 2016
Package DI Number
50885632100862
Quantity per Package
36
Contains DI Package
10885632100864
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |