Duns Number:006261481
Device Description: CUSTOM PACK TL3X86R5 4PK DBL VEN
Catalog Number
-
Brand Name
NA
Version/Model Number
TL3X86R5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K800178,K800178
Product Code
DWE
Product Code Name
TUBING, PUMP, CARDIOPULMONARY BYPASS
Public Device Record Key
5d9fc3b5-1533-43af-94e5-4b5a23da74cf
Public Version Date
December 13, 2018
Public Version Number
4
DI Record Publish Date
May 21, 2016
Package DI Number
20885074526908
Quantity per Package
4
Contains DI Package
00885074526904
Package Discontinue Date
October 24, 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 |