Duns Number:002125419
Device Description: 128 in. (320 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
Catalog Number
-
Brand Name
Standard BodySet® with Needleless Connectors
Version/Model Number
A120-125XSE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 22, 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
K042696,K042696
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
c4230279-d1db-45e5-9efd-e4642a8ec33b
Public Version Date
July 23, 2020
Public Version Number
4
DI Record Publish Date
June 16, 2017
Package DI Number
10818666020266
Quantity per Package
50
Contains DI Package
00818666020269
Package Discontinue Date
July 22, 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 |