Duns Number:008124539
Device Description: Resp-O2 Single Suction Catheter, 6 FR, Sterile, Pediatric Graduated Catheter, Control Valv Resp-O2 Single Suction Catheter, 6 FR, Sterile, Pediatric Graduated Catheter, Control Valve, Coiled Packed
Catalog Number
-
Brand Name
Resp-O2 Single Suction Catheter, 6 FR
Version/Model Number
32000
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
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
BSY
Product Code Name
Catheters, Suction, Tracheobronchial
Public Device Record Key
a5c63435-62ee-4c30-b303-9c143e29b4bd
Public Version Date
May 18, 2022
Public Version Number
1
DI Record Publish Date
May 10, 2022
Package DI Number
00840117310292
Quantity per Package
50
Contains DI Package
00840117310285
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 |