Duns Number:006261481
Device Description: TUBING CB4715R1 10PK CB TMC38 W/6INCH LN
Catalog Number
-
Brand Name
TMC38
Version/Model Number
CB4715R1
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
-
Product Code
DRY
Product Code Name
MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
Public Device Record Key
8c6e67ad-f73a-4c31-9ae8-8910c9005458
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 02, 2017
Package DI Number
20643169790722
Quantity per Package
10
Contains DI Package
00643169790711
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 |