Duns Number:790605856
Device Description: Includes A02 Cardiograph+A0X A Format+D01 All Orders (incl Manual Orders)+D02 ADT Support+ Includes A02 Cardiograph+A0X A Format+D01 All Orders (incl Manual Orders)+D02 ADT Support+D03 DXL ECG Interpretation+D05 ECG Full disclosure+D06 ECG Archive+D08 DICOM ECG result output+D12 Last ECG InterAct Query+D24 Wireless 802 11+D50 A.07.05 (CE7)+E06 Double Sided Tab Clips+H15 Second Battery+H16 Membrane Keyboard+H21 PIM 12 Lead+H23 Long Lead Wires+W02 Bench Repair+M2481A+13943B 10 packs+860309 B01 Partially Assembled Trolley+C02 Storage Bin+C04 Wire Basket
Catalog Number
860429
Brand Name
PageWriter
Version/Model Number
TC50 Government Bundle With Trolley
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
e19b42e9-41d1-4ff5-91c2-f58d5610905a
Public Version Date
July 01, 2022
Public Version Number
7
DI Record Publish Date
September 26, 2018
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 |