Duns Number:039976196
Device Description: AutoTouch Connect reusable autoinjector with optional Bluetooth wireless feature for use w AutoTouch Connect reusable autoinjector with optional Bluetooth wireless feature for use with Enbrel Mini (etanercept) single-dose prefilled cartridge
Catalog Number
-
Brand Name
AutoTouch Connect reusable autoinjector
Version/Model Number
9006940
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
NSC
Product Code Name
Injector, Pen
Public Device Record Key
fc3559bf-b842-45cd-aa53-3628f625cd60
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 2021
Package DI Number
10358406480016
Quantity per Package
15
Contains DI Package
00358406480019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |