Duns Number:092673953
Device Description: Pediatric Elongated CO2/O2 Mask 7' Tubing w/ Threaded Nut, Swivel GSE, 10' x 0.38" ID x .1 Pediatric Elongated CO2/O2 Mask 7' Tubing w/ Threaded Nut, Swivel GSE, 10' x 0.38" ID x .107" OD, Reflective Luer Connectors
Catalog Number
-
Brand Name
Adult CO2 /O2 Mask
Version/Model Number
0931
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"
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
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
fee35355-3a72-42f4-a36d-2c4cce5f83d0
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
May 06, 2019
Package DI Number
10709078006873
Quantity per Package
25
Contains DI Package
00709078006876
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |