Duns Number:790605856
Device Description: Neonatal Single-Patient NIBP Kit contains 50 Cuffs: 5 M1866B Size#1, 10 M1868B Size#2, 20 Neonatal Single-Patient NIBP Kit contains 50 Cuffs: 5 M1866B Size#1, 10 M1868B Size#2, 20 M1870B Size#3, 10 M1872B Size#4, 5 M1873B Size#5. Incorporates new connector configuration and replaces the M1820-60020.
Catalog Number
989803167541
Brand Name
NIBP Cuffs
Version/Model Number
NEONATAL SINGLE-PATIENT NIBP CUFFS
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
324c99d3-fd6a-46eb-960e-c5daebde7e8a
Public Version Date
March 03, 2022
Public Version Number
8
DI Record Publish Date
November 08, 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 |