Duns Number:141668116
Device Description: 3/16in Suction Tubing — 6ft
Catalog Number
RES025-31672
Brand Name
3/16in Suction Tubing — 6ft
Version/Model Number
RES025-31672
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"
Yes
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
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
2b51bcf5-e5db-4705-b63d-38c15a648a2b
Public Version Date
June 26, 2018
Public Version Number
1
DI Record Publish Date
May 26, 2018
Package DI Number
10848530089037
Quantity per Package
10
Contains DI Package
00848530089030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |