Duns Number:198227881
Device Description: BP CUFF NEO-4 1-TUBE SOFT
Catalog Number
30502113SAUNO
Brand Name
Welch Allyn, Inc.
Version/Model Number
901044
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
-
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
a03c3cba-475e-483c-be4a-86f34183ccd3
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
May 12, 2021
Package DI Number
00732094343861
Quantity per Package
40
Contains DI Package
00732094343854
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 |