Duns Number:790605856
Device Description: Philips Holter Software w/ Zymed Alg
Catalog Number
860292
Brand Name
Holter Software
Version/Model Number
Philips Holter Software
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
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
-
Product Code
MLO
Product Code Name
ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
Public Device Record Key
348fb4db-86f7-4341-8ae3-7bf983e0d9dd
Public Version Date
February 21, 2022
Public Version Number
5
DI Record Publish Date
August 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |