Duns Number:040876183
Device Description: TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (0 TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (00811836030006) and one TrenGuard 600 CLASSIC Pack (00811836030174) in a TrenGuard CarryCase with a case of TrenGuard 450 CLASSIC Packs (20811836030086 12 each 00811836030082)
Catalog Number
-
Brand Name
TrenGuard™
Version/Model Number
81012
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
a8f121c5-8990-40de-95be-7f356f948c64
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
August 01, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 28 |