Duns Number:105932508
Device Description: Combo Kit: Royal Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue, Combo Kit: Royal Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue, Latex Free: 60-870-010 PICCOLIGHT® F.O. Xenon 2.5V Otoscope, Black, Latex Free: 20-207-254-L Classic Aneroid Sphygmomanometer, Royal Blue Nylon Cuff, Adult, Latex: 60-405-250 LED Penlight, Metal, Push Button, Cobalt Blue: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-150 Utility scissors 5.5", stainless steel with light blue handle: 80-503-000 Babinski hammer, 8.5"
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-443-344-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)
Yes
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
b85ab2ba-06b0-42b0-be3e-e87eeeade855
Public Version Date
September 23, 2022
Public Version Number
5
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 |