Duns Number:198227881
Device Description: X12+ 12-lead Telemetry Transmitter - 608 MHz, graphic display, alkaline battery, carry cas X12+ 12-lead Telemetry Transmitter - 608 MHz, graphic display, alkaline battery, carry case, and hookup kit; German language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends
Catalog Number
X12PLUS-BDB-XXXXX
Brand Name
Welch Allyn, Inc.
Version/Model Number
901150
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
DRG
Product Code Name
TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Public Device Record Key
3a02fd48-6f2c-4b43-b589-9b86cc9e224e
Public Version Date
June 28, 2022
Public Version Number
2
DI Record Publish Date
May 14, 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 | 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 |