Duns Number:078719435
Device Description: Cool 'N Carry Tote
Catalog Number
17076PM
Brand Name
Ameda, Inc.
Version/Model Number
17076PM
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973501,K973501
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
511156e5-d677-429c-a21a-e5316a3899c2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
10810725020040
Quantity per Package
6
Contains DI Package
00810725020043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |