Duns Number:689719789
Device Description: Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be use Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper.
Catalog Number
-
Brand Name
Autokeeper
Version/Model Number
Safety Pen Needle 31G x 4mm 100PCS
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172095,K172095,K172095
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
9d866163-c055-4a64-ac80-fc6013b9dbeb
Public Version Date
May 21, 2020
Public Version Number
1
DI Record Publish Date
May 13, 2020
Package DI Number
18809445831373
Quantity per Package
4
Contains DI Package
08809445831376
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. | 3 |