Duns Number:022721133
Device Description: Nipple & Nut Standard diss 1240 oxygen fitting Single use. Do not sterilize. 4-24-2019... Nipple & Nut Standard diss 1240 oxygen fitting Single use. Do not sterilize. 4-24-2019...no barcode on current product. Remove from distribution.
Catalog Number
R126797
Brand Name
n/a
Version/Model Number
R126797
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2019
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
BYX
Product Code Name
TUBING, PRESSURE AND ACCESSORIES
Public Device Record Key
bb4b7317-f2c8-4461-811d-27a68e3a6173
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
November 30, 2016
Package DI Number
10607411919531
Quantity per Package
50
Contains DI Package
00607411919534
Package Discontinue Date
April 26, 2019
Package Status
Not 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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |