Duns Number:105932508
Device Description: Combo Kit: Neon Green Carrying Case, 38-416-304 Sprague Rappaport-Type, Adult, Neon Green, Combo Kit: Neon Green Carrying Case, 38-416-304 Sprague Rappaport-Type, Adult, Neon Green, Latex Free, Neon Green Aneroid Sphygmomanometer, Latex Free: 60-840-300-OTO Conventional 2.5V Mini Otoscope, Neon Green, Latex Free with Speculas and Carrying Case, Utility scissors 5.5": 80-170-300 stainless steel with neon green handle
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-372-304-OTO-L
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"
Yes
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
5c39c6a2-dde9-4cdb-9fad-710fcf2d883c
Public Version Date
September 23, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2018
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 | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |