Duns Number:007941230
Device Description: Pressure Infuser Bag Not Made With Natural Rubber Latex Nylon 3000 Cubic Centimeter White Pressure Infuser Bag Not Made With Natural Rubber Latex Nylon 3000 Cubic Centimeter White Disposable/Sngle Use Non Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
233000
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
KZD
Product Code Name
INFUSOR, PRESSURE, FOR I.V. BAGS
Public Device Record Key
8c97727b-da55-446a-bbf0-8614752f49ad
Public Version Date
December 11, 2020
Public Version Number
1
DI Record Publish Date
December 03, 2020
Package DI Number
20885632146173
Quantity per Package
5
Contains DI Package
10885632146176
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 |