Duns Number:006261481
Device Description: CUSTOM PACK TL10G81R2 5PK PLEGIA DUAL P
Catalog Number
-
Brand Name
NA
Version/Model Number
TL10G81R2
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171308,K171308
Product Code
DWF
Product Code Name
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Public Device Record Key
11561045-62fa-4750-a053-ed91b005e85d
Public Version Date
May 31, 2019
Public Version Number
1
DI Record Publish Date
May 23, 2019
Package DI Number
20763000273709
Quantity per Package
5
Contains DI Package
00763000273699
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 |