Duns Number:006261481
Device Description: CELL 1475R1 TMC50 W/6 EXTENSION
Catalog Number
-
Brand Name
TMC50
Version/Model Number
1475R1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
3a1910f5-6abf-4818-9aef-02214a4bbf1a
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 18, 2021
Package DI Number
20763000419930
Quantity per Package
12
Contains DI Package
00763000419936
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 |