Duns Number:600850213
Device Description: Non Sterile Transport Tube - 5 ML - Caps Separate
Catalog Number
TC0101XNS
Brand Name
Typenex Transport Tubes
Version/Model Number
TC0101XNS
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
NNK
Product Code Name
Container, Specimen Mailer And Storage, Non-Sterile
Public Device Record Key
c28cb230-8b2d-495d-a9c3-3d025cc6e26c
Public Version Date
August 19, 2020
Public Version Number
1
DI Record Publish Date
August 11, 2020
Package DI Number
00810050852302
Quantity per Package
1000
Contains DI Package
00810050852319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 39 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |