Duns Number:008124539
Device Description: Resp-O2 Oxygen CO2 Elongated Pediatric Mask, CO2 Sampling Line 2 with a filter, 7' (2.1m) Resp-O2 Oxygen CO2 Elongated Pediatric Mask, CO2 Sampling Line 2 with a filter, 7' (2.1m) Oxygen Tube; male/male connector
Catalog Number
-
Brand Name
Resp-O2 Oxygen CO2 Elongated Mask and CO2 Sampling Line
Version/Model Number
33081
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K143150,K143150
Product Code
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
bee1af48-c209-4a6d-8c2e-0231b7fe6284
Public Version Date
April 30, 2021
Public Version Number
1
DI Record Publish Date
April 22, 2021
Package DI Number
00840117316034
Quantity per Package
25
Contains DI Package
00840117316119
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 |