Duns Number:002125419
Device Description: 85 in. (220 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion 85 in. (220 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump
Catalog Number
-
Brand Name
BodyGuard® Microset with Filter
Version/Model Number
A100-163XESF
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
658f34b6-2c2f-4a2a-a0dd-c64405565467
Public Version Date
November 16, 2020
Public Version Number
4
DI Record Publish Date
June 15, 2017
Package DI Number
10818666020198
Quantity per Package
50
Contains DI Package
00818666020191
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 |