Duns Number:006261481
Device Description: CUSTOM PACK CB2B62R3 5PK VENT-SCKR
Catalog Number
-
Brand Name
NA
Version/Model Number
CB2B62R3
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K891687,K891687
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
ed179600-34f6-4e67-b19f-7327e24aca8d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 20, 2017
Package DI Number
20643169957538
Quantity per Package
5
Contains DI Package
00643169957527
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 |