Duns Number:002125419
Device Description: 12 in. (30 cm) Microset with Female Luer - Blue Stripe, For Use with the BodyGuard® Infusi 12 in. (30 cm) Microset with Female Luer - Blue Stripe, For Use with the BodyGuard® Infusion Pump
Catalog Number
-
Brand Name
BodyGuard® Microset With Female Luer
Version/Model Number
A120-160XPSN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2020
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"
Yes
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
16c70cb2-0c9a-49e9-beda-38930c0fbf3a
Public Version Date
November 16, 2020
Public Version Number
4
DI Record Publish Date
June 21, 2017
Package DI Number
10818666020365
Quantity per Package
50
Contains DI Package
00818666020368
Package Discontinue Date
October 15, 2020
Package Status
Not 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. | 125 |