Duns Number:006261481
Device Description: RESERVOIR 61399401043 1EA BLADDER R14
Catalog Number
-
Brand Name
NA
Version/Model Number
61399401043
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 23, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K882720,K882720,K882720
Product Code
DTN
Product Code Name
RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Public Device Record Key
546648f8-86fb-48fd-ab5c-5328f86015ef
Public Version Date
January 22, 2020
Public Version Number
5
DI Record Publish Date
May 06, 2017
Package DI Number
50613994010433
Quantity per Package
5
Contains DI Package
30613994010439
Package Discontinue Date
July 23, 2018
Package Status
Not 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 |