Duns Number:007941230
Device Description: Kit Port Access Includes 1 Tray 4 Gauze 2X2 1 Prefilled Syringe 1 Tegaderm 3.5X4.5 1 Towel Kit Port Access Includes 1 Tray 4 Gauze 2X2 1 Prefilled Syringe 1 Tegaderm 3.5X4.5 1 Towel White 23X24 1 Towel White Kaycel 1 Header Bag 10X15 1 Alcohol Swabstick Single 1 Skin Wipe 1 Chloraprep 1 Card Tape Strips 1 Hand Sanitizer 1 Label 1 Mask Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
PA1010
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K921394,K921394
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
d740b3ef-f9c7-41f3-b6bf-ed054e4f08b4
Public Version Date
October 06, 2020
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50885632136670
Quantity per Package
20
Contains DI Package
10885632136672
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 |