Duns Number:008124539
Device Description: Resp-O2 Spring Loaded T-Adaptor 22mm OD x 22mm OD
Catalog Number
-
Brand Name
Resp-O2 Spring Loaded T-Adaptor
Version/Model Number
34500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
f3d97820-2dd9-42df-97c3-a4868482155a
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 22, 2021
Package DI Number
00840117312166
Quantity per Package
30
Contains DI Package
00840117312159
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |