Duns Number:002125419
Device Description: Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles up to 50 m Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles up to 50 mm in diameter (1), keys (2), Instructions for Use (1).
Catalog Number
-
Brand Name
500ml Ultimate Lockbox
Version/Model Number
190-900PXCVP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2020
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
bb7ac388-b59b-4ad4-b6ae-c898daeb7251
Public Version Date
July 04, 2022
Public Version Number
6
DI Record Publish Date
January 11, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 125 |