Duns Number:198227881
Device Description: TAGECG WEARABLE SENSOR
Catalog Number
TAGECG-1
Brand Name
Welch Allyn, Inc.
Version/Model Number
901098
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
K162503,K162503
Product Code
DSH
Product Code Name
RECORDER, MAGNETIC TAPE, MEDICAL
Public Device Record Key
13f94c18-57f2-4b4c-b41a-992c379e44ac
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
September 01, 2017
Package DI Number
00732094212471
Quantity per Package
5
Contains DI Package
00732094246896
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |