Duns Number:008124539
Device Description: Resp-O2 Suction Catheter Kit, 14 FR, Mini-TrayContents:1 One-Compartment Mini-Tray1 Adult Resp-O2 Suction Catheter Kit, 14 FR, Mini-TrayContents:1 One-Compartment Mini-Tray1 Adult Graduated Catheter with Control Valve1 Pair of Powder-Free Vinyl Gloves
Catalog Number
-
Brand Name
Resp-O2 Suction Catheter 14 FR Mini-Tray
Version/Model Number
32083
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
86a7f2b6-24f0-4d7f-a582-d0c09a1c29d6
Public Version Date
April 29, 2022
Public Version Number
1
DI Record Publish Date
April 21, 2022
Package DI Number
00840117313507
Quantity per Package
100
Contains DI Package
00840117313514
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 |