Duns Number:008124539
Device Description: Resp-O2 Suction Catheter Kit, 8 FR, Mini-TrayContents:1 One-Compartment Mini-Tray1 Pediatr Resp-O2 Suction Catheter Kit, 8 FR, Mini-TrayContents:1 One-Compartment Mini-Tray1 Pediatric Graduated Catheter with Control Valve1 Pair of Powder-Free Vinyl Exam Gloves
Catalog Number
-
Brand Name
Resp-O2 Suction Catheter Kit 8 FR Mini-Tray
Version/Model Number
32080
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
0246d8d4-2f10-4d65-8a74-6614cf6483f3
Public Version Date
April 29, 2022
Public Version Number
1
DI Record Publish Date
April 21, 2022
Package DI Number
00840117313446
Quantity per Package
100
Contains DI Package
00840117313453
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 |