Duns Number:058701385
Device Description: MF-Tuohy Borst Adpaters (MF FLOW30, Male Spin/Lock, Pediatric)
Catalog Number
-
Brand Name
MF-Tuohy Borst Adpaters (FLO30, Male Spin/Lock, Pediatric)
Version/Model Number
MF-Touhy Borst Adapters
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
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
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
cf33058e-2c87-443c-9b16-078071cc9504
Public Version Date
September 29, 2022
Public Version Number
2
DI Record Publish Date
November 08, 2021
Package DI Number
10855950006520
Quantity per Package
25
Contains DI Package
00855950006523
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
card board box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 63 |