Duns Number:790605856
Device Description: PageWriter TC70 US Government all-inclusive bundle with trolley Includes A02 Cardiograph+D PageWriter TC70 US Government all-inclusive bundle with trolley Includes A02 Cardiograph+D01 All 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 abgn SWHW+D50 WIN CE7+E06 Double Sided Tab Clips+H15 Second Battery+H16 Membrane Keyboard+H21 PIM 12 Lead+H23 Long Lead Wires+W01 Onsite Repair+M2481A+13943B 10packs+860318 B01 Partially Assembled Trolley+C02 Storage Bin+C04 Wire Basket
Catalog Number
860352
Brand Name
PageWriter
Version/Model Number
TC70 government Bundle w 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
cea58340-7a3c-4eca-8a78-90a4b948fea4
Public Version Date
July 01, 2022
Public Version Number
11
DI Record Publish Date
September 20, 2016
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 |