Duns Number:015222912
Device Description: Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with la Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each.
Catalog Number
58011
Brand Name
MACS
Version/Model Number
58011
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080692,K080692
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
38a38c35-2bb7-47f7-b017-0d9099f2a0a7
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
00853678006085
Quantity per Package
10
Contains DI Package
00853678006078
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |