Duns Number:006261481
Device Description: BAG ELUWB1 UNIV WASTE 10 LITER 10CA
Catalog Number
-
Brand Name
NA
Version/Model Number
ELUWB1
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
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
K812292,K812292
Product Code
CAC
Product Code Name
APPARATUS, AUTOTRANSFUSION
Public Device Record Key
b9a4245e-4dd6-47a3-bc26-f79a5ff0d25f
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
June 17, 2015
Package DI Number
10673978523740
Quantity per Package
10
Contains DI Package
00673978523743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |