Duns Number:827221698
Device Description: AN LEGACY PRO PUMP ONLY,
Catalog Number
-
Brand Name
American National
Version/Model Number
APM-AN-8000-LP-PUMP
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
-
Product Code
FNM
Product Code Name
Mattress, Air Flotation, Alternating Pressure
Public Device Record Key
88015338-a9e5-4116-83ce-4afc25fddbad
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 06, 2016
Package DI Number
30092237618166
Quantity per Package
4
Contains DI Package
00092237618165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 62 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |
U | Unclassified | 2 |