Duns Number:012177531
Device Description: NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
Catalog Number
185459
Brand Name
NovoPen Echo®
Version/Model Number
185459
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
-
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
K162602,K182387,K162602,K182387
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
c1f2ce55-8d94-40ca-bdea-a4e2bde80b5c
Public Version Date
April 03, 2019
Public Version Number
4
DI Record Publish Date
November 23, 2016
Package DI Number
30301691854592
Quantity per Package
16
Contains DI Package
00301691854591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |