Duns Number:198227881
Device Description: Z2 + Thermal printer in cool gray with 8.5 in. x 11 in. paper and accessories. Includes Z2 + Thermal printer in cool gray with 8.5 in. x 11 in. paper and accessories. Includes additional Spacer part for use with A4 paper
Catalog Number
34000-025-1003
Brand Name
Welch Allyn, Inc.
Version/Model Number
901006
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)
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
b51518ee-df2f-4fdb-8614-58dc08c06233
Public Version Date
June 24, 2022
Public Version Number
2
DI Record Publish Date
September 26, 2019
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |