Duns Number:002125419
Device Description: 120 in. (305 cm) Microset with Filter and Y Site - Blue Stripe, For Use with the BodyGuard 120 in. (305 cm) Microset with Filter and Y Site - Blue Stripe, For Use with the BodyGuard® Infusion Pump
Catalog Number
-
Brand Name
BodyGuard® Microset w/ 0.2 mic filter and lower y-site with female luer
Version/Model Number
A120-160XYSF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
Issuing Agency
In HIBCC
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
K042696,K042696
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
dd252472-516c-40c8-bd14-5821f0408115
Public Version Date
July 09, 2020
Public Version Number
4
DI Record Publish Date
August 22, 2016
Package DI Number
B101A120160XYSF1
Quantity per Package
16
Contains DI Package
B101A120160XYSF0
Package Discontinue Date
November 04, 2019
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 |