Duns Number:790605856
Device Description: Mobile CL Disposable Small Adult Cuff (light blue). Circumference 21.0 - 27.0 cm. Used wit Mobile CL Disposable Small Adult Cuff (light blue). Circumference 21.0 - 27.0 cm. Used with the IntelliVue CL NBP Pod. Quantity 20 cuffs.
Catalog Number
989803163181
Brand Name
NIBP Cuffs
Version/Model Number
Mobile CL Disposable Small Adult Cuff
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
2757c87e-6c6b-440e-b19c-58e90fce19f3
Public Version Date
September 21, 2022
Public Version Number
8
DI Record Publish Date
December 26, 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 |