Duns Number:092673953
Device Description: Respiratory Adaptor (15 mm ID x 22 mm OD) w/Luer Port and Female Luer Lock Cap
Catalog Number
-
Brand Name
Respiratory Adaptor W/Luer Port, Cap
Version/Model Number
0400
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
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
BXY
Product Code Name
Flowmeter, Calibration, Gas
Public Device Record Key
496621ba-6074-4e6e-937f-41f2f99ad0d5
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 31, 2020
Package DI Number
10709078008983
Quantity per Package
50
Contains DI Package
00709078008986
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |