Duns Number:488293218
Device Description: Suction jar lid with conical patient connection 6-10 mm and overflow device, OKM, K7503760
Catalog Number
-
Brand Name
Suction jar lid with conical patient connection and overflow device
Version/Model Number
080.0042
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150134,K150134
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
3b47c417-4880-4f20-9074-91df853b9b4e
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
October 24, 2016
Package DI Number
07612367052689
Quantity per Package
32
Contains DI Package
07612367006514
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 93 |