Duns Number:058614483
Device Description: Nasal Mask CPAP Interface,Shallow Cushion
Catalog Number
Y-103075-00A
Brand Name
Puritan Bennett
Version/Model Number
Y-103075-00A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 26, 2019
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
K002001,K002001
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
591cc0ad-40ec-4b32-8766-2a3c75b9c66c
Public Version Date
December 06, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521135079
Quantity per Package
200
Contains DI Package
20884521135076
Package Discontinue Date
August 26, 2019
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 |