Duns Number:058614483
Device Description: Soft Headgear CPAP Interface Circuit Kit,Large, Standard Shell
Catalog Number
-
Brand Name
Puritan Bennett
Version/Model Number
Y-100872-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K900164,K900164
Product Code
BYE
Product Code Name
Attachment, breathing, positive end expiratory pressure
Public Device Record Key
1563ef6a-6473-4049-896b-c311a01f43b9
Public Version Date
September 19, 2022
Public Version Number
4
DI Record Publish Date
September 03, 2015
Package DI Number
10884521134683
Quantity per Package
20
Contains DI Package
20884521134680
Package Discontinue Date
February 21, 2021
Package Status
Not 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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |