Duns Number:690543319
Device Description: TERUMO SAMPLING SITE COUPLER
Catalog Number
-
Brand Name
TERUMO SAMPLING SITE COUPLER
Version/Model Number
TC*MP1
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
-
Product Code
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
0a980d1f-3f42-4ed4-ab1e-2b1fe7ee33b0
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
54987350731277
Quantity per Package
20
Contains DI Package
34987350731273
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 364 |
3 | A medical device with high risk that requires premarket approval | 29 |